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The Deadly Medical Devices that Were Recalled in 2020

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.

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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

table of FDA recalled medical devices of 2020

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

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