Medical Device Recall Statistics

Modern medical devices have improved patient outcomes by preventing and treating challenging medical conditions. However, manufacturers designing, building, and distributing defective medical devices into the medical market tend to cause more harm than help.

Are you the victim of a defective medical device and have a need to undergo revision surgery? Have you lost a loved one from a dangerous implant caused by a defective design of a product on the market?

The personal injury attorneys at the law firm of Rosenfeld Injury Lawyers LLC fight aggressively on behalf of our injured clients to ensure they receive the compensation they deserve.

Contact our law office today at (888) 424-5757 (toll-free phone number) or through the contact form to schedule a free consultation. We have represented thousands of injured patients nationwide, winning hundreds of millions of dollars on their behalf.

Nearly every year, the FDA initiates mandatory or voluntary medical device recalls from the market, correcting or removing products violating their safety standards. Medical device recalls protecting the public from designers, makers, and distributors’ units “that present a risk of injury or gross deception or are otherwise defective.”

Many medical devices recalls involve units implanted during a surgical procedure or medical treatment, including artificial hips, biologics, blood, and vaccines.

FDA-Mandated Medical Device Recall Statistics

In recent years, the FDA (Food and Drug Administration) has issued recalls of more medical devices than at any other time and medical history. Some recalls of units are from the medical marketplace due to the inadequate labeling and information they provide, which is often the responsibility of the unit’s designer, maker, and distributor.

Sometimes a defective design is not found immediately because the device manufacturer rushed to test the product to ensure it reached users quickly to recover the high research and development costs.

Other statistics involving a number of medical device recalls include:

• In 2016 and 2017, the FDA issued recalls of nearly 410 million medical units, or approximately 58 million units every quarter
• During 2018, the average number of $58 million per unit the previous year (2017) rose to nearly 100 million units issued a recall each quarter, a massive jump of nearly 71%
• The government shutdown in early 2020 likely caused the drop in FDA medical device recalls from the previous year when there was little analysis and data on products with a defective design
• Inadequate information, rushing to test the product, minimizing adverse information, and faulty designs are the leading reasons for medical device recalls
• A small percentage of medical device recalls are the result of the manufacturer, distributor, or reseller providing insufficient warning systems to identify any healthcare problems before a severe injury or death happens
• Statistics show that the common health problems associated with recalling a medical unit from the marketplace include its dangers, failure to conform, and not meeting government requirements
• Data shows that approximately 17% of all medical device liability cases involve inadequate (defective) device designs
• Statistics show software issues remain the leading cause of the most significant number of medical device recalls
• The federal agency may recall medical devices after an initial approval after researchers identify health problems that lead to the injury or wrongful death of patients
• Many medical device manufacturers and doctors have been held legally accountable and financially responsible for using any device for “off-label” use, meaning using the unit outside of its specific purpose
• Most defective medical device cases involve internal implant components loosening inside the body, like hip and knee implants
• Data shows that nearly 55% of all medical device recall cases involve units sold throughout the United States, compared to approximately 36% of all worldwide devices issued a recall that was sold in the global market
• Many medical devices issued a recall because the manufacturing organization provided inadequate information about installation care, providing misinformation to the patient open to making an informed decision about using the device
• The FDA issues nearly six medicine and medical device recalls on average every month
• Statistics reveal that the number of Class I (life-threatening) FDA medicine and medical device recalls have skyrocketed since 2015
• Some medical devices will lead product material into the patient, but breast implants and internal joint lubrication pumps
• The FDA’s mandatory medical device recalls typically start with a notification order, followed by a cease to distribute the product, often after a catastrophic event occurs
• The FDA typically requires a mandatory recall if there is “a reasonable probability that the medical unit will cause serious adverse health consequences or death (21 USC 360h(e))
• Most medical device makers invest millions of dollars in new technologies and can only recoup their product development investment after the units are sold through the medical marketplace
• Medical device manufacturers will apply to the immediate FDA approval process after positive clinical trials that, before worldwide use reveals any long-term health problems
• Some medical device makers continued to sell their defective devices months or years after the FDA recalls the product, and the number of medical issues continues to grow

Some manufacturers ignore or minimize any adverse information about their medical device while rushing to get the product to the medical marketplace, paying millions or billions of dollars to resolve civil lawsuits and claims in spite of any design defects.

Medical Device Recalls for 2020 in the United States

The FDA initiated massive-scale recalls involving medications and medical devices in 2020 to ensure consumer safety. Statistically, the FDA issued recalls for more medical devices and medicines involving a number of companies’ design defects in 2020 than the previous year. The FDA list includes:

• Abbott Vascular (2/19/2020) – the FDA recalls NC Trek RX and NC Traveler RX Coronary Dilatation Catheters because of a balloon failure
• Applied Medical (5/12/2020) – The FDA issued a recall for Python Embolectomy, BARD Embolectomy, and OTW Latis Cleaning Catheters because of the potential of separation during use
• Arrow International Inc. (7/2/2020) – The federal agency recalls the Arrow AutoCAT®2 and AC3 Optimus® IABP Series because of a possible motor wire connector breakdown
• Baxter Healthcare (12/1/2020) – The FDA recalls the company’s Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software because of an unplanned issue
• Becton Dickinson (BD) CareFusion 303 Inc. (3/6/2020) – the FDA recalls Alaris System Infusion Pump products because of system and software issues
• Becton Dickinson (BD) CareFusion 303 Inc. (9/16/2020) – The FDA issued a recall for Alaris™ Syringe and Alaris™ PCA Module products because of possibly incorrect displays of syringe sizes and types
• Becton Dickinson (BD) CareFusion 303 (9/14/2020) – the FDA recalls Alaris System Infusion Pumps because of damaged Inter-Unit Interface Connectors, missing or loose battery screws, and broken lower and upper hinge posts and the membrane frame
• Becton Dickinson (BD) CareFusion 303, Inc. (9/14/2020) – The FDA recalls Alaris™ System PC Unit and PC Unit Front Case Keypad Replacement Kits because of the risk of sticking or unresponsive Keys
• Becton Dickinson CareFusion 303, Inc. (10/2/2020) – The FDA issued a recall for Alaris™ System Pump Module and Module Door Replacement kit products because a potentially stuck or unresponsive keys
• Boston Scientific Corporation (4/7/2020) – The FDA recalls Imager II Angiographic Catheters because of Tip detachment
• CME America (3/30/2020) – The FDA recalls the company’s BodyGuard Infusion Pump System products because of the potential risk of over-infusion or under infusion
• CME America (3/18/2020) – The FDA recalls the company’s BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System because of the possible risks of under infusion
• CME America Updates (8/5/2020) – The FDA issued a recall for the company’s BodyGuard Infusion Pump System because of potential risks of under-infusion or over infusion
• Cook Medical (11/12/2020) – The Food and Drug Administration recalls the company’s Fixed Core Wire Guides because of unit damage from a unit maker’s mistake
• Distributor Teleflex (1/28/2020) – The FDA recalls the Galemed Babi Plus Pressure Relief pump products because of a dislodged valve
• Endologix Inc. (6/16/2020) – The FDA recalls the company’s Ovation iX Abdominal Stent Graft Systems due to possible risks of polymer leaks during implantation
• GE Healthcare (2/4/2020) – The Food and Drug Administration issued a recall for the company’s CARESCAPE Respiratory Module products because of incorrect oxygen valves
• GE Healthcare (2/7/2020) – The FDA recalls GE Healthcare’s Carestation 600 Series Anesthesia Systems because of the loss of mechanical ventilation
• King Systems (2/27/2020) – The FDA recalls King System’s King Vision Video Laryngoscope Adapter products size .5 because the screen displayed a reversed image
• LeMaitre Vascular Inc. (4/2/2020) – The FDA recalls the LeMaitre Over the Wire Embolectomy Catheter because a balloon deflation in separation issues
• Medtronic (5/28/2020) – The FDA recalls the HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief because of the probable risk of breaks and tears during setup
• Medtronic (2/12/2020) – The Food and Drug Administration recalls Medtronic’s MiniMed Insulin Pump products due to incorrect insulin dosing
• Medtronic (3/30/2020) – The Food and Drug Administration recalls Medtronic’s Pipeline Flex Embolization Devices because of the potential risk of a unit fracture
• Medtronic (11/3/2020) – The Food and Drug Administration recalls Medtronic’s Rashkind Balloon Septostomy Catheter products due to quality problems
• Medtronic (6/1/2020) – The regulating agency recalls Medtronic’s StealthStation auto-registration feature because of inaccuracies during DBS (deep brain stimulation) procedures
• ResMed (2/19/2020) – The FDA recalls ResMed’s Stellar 100 and 150 Non-invasive and Invasive Ventilator products because of a sound alarm failure
• Smiths Medical (8/24/2020) – The Food and Drug Administration recalls Smiths Medical’s Medfusion 3500 and 4000 Syringe Pump products for probable risk of a medicine delivery mistake
• Stryker Neurovascular (11/9/2020) – The Food and Drug Administration recalls the Trevo XP ProVue Retriever because the core wire could break or separate during use
• Teleflex Medical (2/19/2020) – The FDA recalls the company’s Comfort Flo Humidification System products because of a malfunction that might cause water to enter the airway
• Tytek Medical (2/25/2020) – The regulating agency recalls Tytek Medical’s TM-317 PneumoDart-Pneumothorax Needle products because of partially or fully blocked needles
• Vascular Solutions, Inc. (4/30/2020) – The Food and Drug Administration recalls Vascular Solutions’ Langston Dual Lumen Catheter because of the risk of separation during use
• Verathon, Inc. (7/17/2020) – The regulating agency recalls the company’s GlideScope Core One TouchSmart Cable (“OneTouch cable”) products because of a complete or partial loss of the display image during use

Largest Worldwide Medical Device Recall Statistics

The United States Congress formed the Food and Drug Administration in 1906 to regulate the safety of approved medicines in the United States. The law signed by Pres. Theodore Roosevelt established the agency that would regulate prescription medications and over-the-counter (OTC) medications to ensure the purity and safety of a number of products, including food, cosmetics, dietary products, dietary supplements, medical devices, and more.

By 1912, the US Supreme Court gutted the law, ruling that the agency could not handle falsifying claims involving efficacy. Congress amended the law the following year.

In time, the FDA initiated device analysis, inspections, and mandatory/voluntary medical device recalls of previously approved medications and devices to protect the public’s welfare and ensure safety.

The Johnson & Johnson organization has participated in numerous recalls through various subsidiaries, including McNeil, Janssen, LifeScan, Johnson & Johnson Pharmaceuticals, Ortho, Ethicon, Depuy, Cilag, Acclarent, Advanced Sterilization Products, Animas Corporation, Acuvue, Actelion, Biosense Webster, and Neutrogena.

The ten most significant medical device recalls occurring worldwide involving Class I, Class II, and Class III device inspections include:

• West Pharmaceutical – The pharmaceutical company issued a recall for nearly 39 million fluid transfer system units
• Magellan Diagnostics – Over 7 million blood lead testing systems were recalled
• Cook Medical – The company recalled over 4 million catheters
• Abbott Industries – The medical device maker issued a recall for more than 465,000 cardiac pacemakers
• Nurse Assistant – The company recalled over 386,000 saline flush IV syringes
• Care Fusion – The company recalled more than 382,500 Alaris pump modules
• Dexcom – Over 263,500 glucose monitoring systems were recalled
• ICU Medical – Nearly 222,000 vial spike units were recalled
• Abbott Industries – Abbott was required to recall Abbott voluntarily recalled over 175,600 defibrillators
• Medtronics – Nearly 157,000 dual-chamber pacemakers were recalled
• Cardinal Health voluntarily recalled over 9 million surgical grounds
• Cardinal Health recalled more than 2.5 million Pre source Procedure Packs, costing over $96 million
• Fourteen pharmaceutical companies voluntarily issued a recall for Zantac and other ranitidine-containing products after the agency found unacceptable levels of N-nitrosodimethylamine (NDMA)

Numerous companies recalled millions of hand sanitizer bottles in mid-2020 after the FDA published a list of dangerous toxic substances, including methanol in 55 sanitizing brands that would be hazardous if ingested or absorbed through the skin.

Dangerous Medical Products

Typically, medical device recalls involving units that pose severe risks to patients and outweigh any medical advantage when using the product. Typically, recalls of medical devices have been because they violated federal law, pose a significant medical consequence, or are defective.

In many cases, the manufacturer or designer released a defective product and knew or should have known there was an issue. The FDA may require that the manufacturer relabeled the product, notified patients of any probable adverse medical consequences of using the device, or monitor patients to identify any possible health problems by using the device.

Often, the voluntary medical device recall results in temporary or total removal of the medical device from use. At this stage, many patients have likely suffered grave consequences or experienced severe injuries from the use of the device or after it was implanted.

Medical Device Categories

The FDA issues mandatory and voluntary recalls and product safety communications to inform the public of defective equipment, medical devices, cosmetics, supplements, and medicines and all probable side effects.

The Food and Drug Administration categorizes medical devices into 3 categories that include:

• Class I – Using or exposure to a defective medical device will result in severe or fatal injury
• Class II – Using or exposure to a defective medical device might cause a medically reversible or temporary medical consequence
• Class III – Using or exposure to a defective medical device will likely not cause a number of medical consequences

Under all product recall classes involving medical devices, the FDA identifies the problem through the recall procedure at nine specific levels that include:

• Correction – The agency might recommend correcting the problem without physically removing the unit from the patient’s body or other location. These actions might involve repairing, modifying, adjusting, relabeling, or inspecting the device through patient monitoring.

• Routine servicing – The FDA might insist on scheduled maintenance involving the medical device, replacing components after its life expectancy, executing calibrations, replacing batteries, or correctly responding to typical wear and tear.

• Market withdrawal – The agency might initiate legal action to correct or remove the product, even when there is no violation.

• Stock recovery – The agency may require the unit maker and distributor to remove or correct any device not yet sold in the medical marketplace while still under the manufacturer’s direct control, not in the supply chain. Stock recovery might involve devices remaining on the manufacturer’s premises requiring corrective action or removal.

• Device enhancement – The device maker might enhance the medical device to improve its performance or quality and is not usually used to remedy an FDA violation, like changing its appearance or increasing its safety.

• Safety alert – The agency may initiate device recalls due to the possible risk of substantial harm. For example, the federal agency may order the removal of the medical device from the marketplace to avoid any probable adverse health consequence or preventable death.

• Insufficient labeling – The agency recall may require the manufacturer or distributor to relabel the product that has misleading or false information or does not provide adequate directions to use the device properly. Sometimes, the manufacturer or distributor can avoid a recall under the FD&C Act by adding a new warning label to meet the proper labeling requirements.

• Government regulation non-compliance – The agency may initiate a medical device recall through a safety communications report if the manufacturer or distributor incorrectly moved toward removing or correcting defective marketed medical products to ensure it remains in compliance.

• Failing to meet specifications – Any designer, manufacturer, or distributor of a medical device that misrepresents the product could be guilty of a crime under Food and Drug Administration rules and regulations. A failure to meet specifications often involves an alteration that adulterates the product as defined under the FD&C Act.

Don’t Be a Statistic. Contact a Medical Device Injury Attorney Today to Handle Your Compensation Case

Did the use of a medical device harm you, or did you lose a loved one from a defective component or dangerous medicine? Our medical device lawyers can help you pursue the financial compensation your family deserves.

Contact the personal injury attorneys at the law firm of Rosenfeld Injury Lawyers LLC at (888) 424-5757 (toll-free phone number) or through the contact form today to schedule a free consultation today. All information you share with our law offices remains confidential through an attorney-client relationship.

Let our defective medical device litigation team evaluate the evidence and provide legal options on how to proceed. We accept all cases involving medical device recalls through contingency fee agreements, meaning you pay us nothing until we have successfully resolved your case.

Our law firm currently follows CDC (Centers for Disease Control and Prevention) Covid-19 (coronavirus) social distancing guidelines to ensure everyone’s safety.

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