The FDA publishes a public list of the devices that have been recalled for safety. In 2020 there were 23 devices that were recalled. If you or a loved one had a medical procedure using one of these devices and there were significant complications leading to a serious injury or death, you should contact an attorney that specializes in medical malpractice. See the chart at the bottom of this article for the full list of products recalled in 2020 by the FDA.
The following products resulted in patient deaths:
Trevo XP ProVue Retriever
Device type: The device is intended to restore blood flow or remove blood clots within a blood vessel in the brain during an acute ischemic stroke.
Reason for Recall: There is a risk the core wire may break or separate during use, causing the device to be left inside the patient’s blood vessel or tissue. This could cause bleeding, additional blockage of blood vessels, disability, and death.
The Rashkind Balloon Septostomy Catheters
Device type: The catheters are used to create an atrial septal defect or to enlarge an existing atrial septal defect as a treatment option for patients with Cyanotic Congenital heart defects.
Reason for Recall: Device quality issues that may lead to the device breaking, separating or failing during use, which may cause serious damage to blood vessels (vascular injury) and death.
Alaris System Infusion Pumps
Device Type: An infusion pump and vital signs monitoring system. The system is used in adult, pediatric and neonatal care.
Reason for Recall: Various mechanical and hardware failures that can lead to injuries and death.
The Pipeline Flex Embolization Device (“Pipeline Flex”)
Device Type: A permanent mesh cylinder (stent) intended for the treatment of brain aneurysms that bulge or balloon out the sides of the blood vessel (wide-neck and fusiform). It also includes the delivery system.
Reason for Recall: There is a risk the delivery system could fracture while placing the stent inside the patient. The remaining pieces or the attempts made to retrieve them can make the condition worse or can cause other problems, such as continued blockage of blood vessels, stroke, and death.
The NC TREK RX Coronary Dilatation Catheter
Device type: Coronary dilation catheters are used to open clogged blood vessels to improve blood flow to the heart.
Reason for Recall: The balloons from the impacted lots may not deflate as intended, which can cause serious adverse health consequences, such as prolonged cardiac ischemia (reduced blood flow to the heart), air embolism, thrombosis (clot in the artery), myocardial infarction (heart attack), and additional surgery that could lead to postoperative complications, including death.
Stellar 100 and 150 Non-invasive and Invasive Ventilators
Device Type: Non-invasive (air pushed through a mask or mouthpiece) and invasive (air pushed through a tube into the windpipe) ventilators are used to provide breathing support to adult and pediatric patients who are non-ventilator dependent and spontaneously breathing.
Reason for Recall: The sound alarm may fail to work, which can lead to serious injury or death.
MiniMed Insulin Pumps
Device Type: For people with Type 1 diabetes the insulin pump is intended to deliver insulin for the management of diabetes.
Reason for Recall: A missing or broken retainer ring which helps to lock the insulin cartridge can result in under or over delivery of insulin, which could result in a loss of consciousness, seizure, and death.
Many more devices resulted in injuries or presented dangers that could lead to serious injury or death. This chart shows the complete list as of May 20, 2021. If you suspect you or your loved one was injured as a result of using one of these products, it would be wise to contact an attorney that specializes in medical malpractice.
DEVICE & ISSUE | DATE | COMPLAINTS | INJURIES | DEATHS |
Cook Medical Recalls Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers Due to Separation in Device | 12/23/20 | 57 | 14 | 0 |
Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software Due to Unplanned Shutdown Issues | 12/01/20 | 17493 | 16 | 0 |
Cook Medical Recalls Fixed Core Wire Guides, Due to Device Damage from a Manufacturing Error | 11/12/20 | 0 | 0 | 0 |
Stryker Neurovascular Recalls Trevo XP ProVue Retriever Due to Core Wire That May Break or Separate During Use | 11/09/20 | NL | 11 | 1 |
Medtronic Recalls Rashkind Balloon Septostomy Catheters for Quality Issues | 11/03/20 | 2 | 1 |
Becton Dickinson CareFusion 303, Inc. Recalls Alaris™ System Pump Module and Pump Module Door Assembly Replacement Kits Due to the Potential for Stuck or Unresponsive Keys | 10/02/20 | 976 | 0 | 0 |
Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris™ Syringe and Alaris™ PCA Modules Due to Potential Incorrect Display of Syringe Types and/or Sizes | 09/16/20 | 976 | 0 | 0 |
Becton Dickinson (BD) CareFusion 303, Inc. Recalls Alaris™ System PC Unit and PC Unit Front Case Keypad Replacement Kits Due to Risk of Stuck or Unresponsive Keys | 09/14/20 | 1186 | 1 | 0 |
Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Pumps Due to Risk of Medication Delivery Error | 08/24/20 | 4 | 1 | 0 |
CME America Updates Recall of BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion | 08/05/20 | 165 | 0 | 0 |
Verathon, Inc. Recalls GlideScope Core One TouchSmart Cable (“OneTouch cable”), Due to partial or complete loss of image during use | 07/17/20 | 74 | 0 | 0 |
Arrow International Inc. Recalls Arrow AutoCAT®2 and AC3 Optimus® IABP Series Due to Possible Breakdown of Motor Connector Wires | 07/02/20 | 30 | 0 | 0 |
Endologix Inc. Recalls Ovation iX Abdominal Stent Graft Systems Due to Risks of Polymer Leaks During Implantation | 06/16/20 | NL | NL | NL |
Medtronic recalls StealthStation auto-registration feature due to inaccuracies during deep brain stimulation (DBS) procedures | 06/01/20 | 33 | 11 | NL |
Medtronic Recalls HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Due to Risk of Breaks and Tears During Set Up | 05/28/20 | 92 | NL | NL |
Applied Medical Recalls Python Embolectomy, BARD Embolectomy, and OTW Latis Cleaning Catheters Due to Risk of Separation During Use | 05/12/20 | 46 | 0 | 0 |
Vascular Solutions, Inc. Recalls Langston Dual Lumen Catheter Due to Risk of Separation During Use | 04/30/20 | 8 | 0 | 0 |
Boston Scientific Corporation Recalls Imager II Angiographic Catheters Due to Tip Detachment | 04/07/20 | NL | 9 | NL |
LeMaitre Vascular Inc. Recalls LeMaitre Over the Wire Embolectomy Catheter Due to Balloon Deflation and Separation Issue | 04/02/20 | 26 | 1 | 0 |
CME America Recalls BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion | 03/30/20 | 158 | 0 | 0 |
Medtronic Recalls Pipeline Flex Embolization Devices Due to Risk of Device Fracture | 03/30/20 | 50 | 10 | 1 |
CME America Recalls BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System Due to Risk of Under-Infusion | 03/18/20 | 3 | 0 | 0 |
Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris System Infusion Pumps Due to Software and System Errors | 03/06/20 | NL | 55 | 1 |
King Systems Recalls King Vision Video Laryngoscope Adapter Size ½ Due to a Display of The Reversed Image | 02/27/20 | NL | 0 | 0 |
Tytek Medical Recalls TM-317 PneumoDart-Pneumothorax Needle Due to Fully and Partially Blocked Needles | 02/25/20 | 1 | 0 | 0 |
Abbott Vascular Recalls NC Trek RX and NC Traveler RX Coronary Dilatation Catheters Due to Failure of Balloon (diameter 4.0mm, 4.5mm and 5.00mm) to Deflate | 02/19/20 | 13 | 0 | 1 |
Teleflex Medical Recalls Comfort Flo Humidification Systems Due to Malfunction That May Cause Water to Enter Airway | 02/19/20 | 102 | 8 | 0 |
ResMed Recalls Stellar 100 and 150 Non-invasive and Invasive Ventilators Due to Sound Alarm Failure | 02/19/20 | NL | NL | 1 |
Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing | 02/12/20 | 26421 | 2175 | 1 |
GE Healthcare Recalls Carestation 600 Series Anesthesia Systems Due to Loss of Mechanical Ventilation | 02/07/20 | NL | 0 | 0 |
GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Incorrect Oxygen Values | 02/04/20 | NL | 0 | 0 |
Distributor Teleflex Recalls the Galemed Babi.Plus Pressure Relief Manifolds Due to Dislodged Valve | 01/28/20 | 0 | 0 | 0 |