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10 Biggest Medical Device Recalls of 2016

2016 was a big year for medical device recalls, with the number of units recalled in the third quarter reaching the highest level in four years. Here are the 10 recalls that impacted the most medical device units in the United States.

 Medical device recalls hit a high in the third quarter of 2016, according to a Q3 report from theStericycle ExpertSolutions Recall Index. That report found that the number of device recalls in the quarter was the highest observed since 2000 and the number of recalled units was the highest seen since the third quarter of 2012.

We reviewed FDA’s medical device recall database to find the largest device recalls of the year. All of these recalls were categorized as Class I recalls, the most serious type, by the agency.

The 10 recalls listed here were ranked by the number of units affected in the United States. 

 

Cook Medical

Device:Cook Medical’s Single Lumen Central Venous Catheter Sets and Trays; Single Lumen Pressure Monitoring Sets and Trays; Femoral Artery Pressure Monitoring Catheter Sets and Trays; Radial Artery Pressure Monitoring Catheter Sets and Trays.

Recall reason:According to information on the FDA recall page, “the tips may split or separate from the catheters due to a manufacturing error . . . the tip could enter the patient’s blood stream. This could cause serious injury to the patient . . . or cause death. Tip splitting or separation may also cause the device to stop working.”

At the time, FDA said it had 13 medical device reports of serious adverse events and one death.

When recall was initiated:January 6, 2016

Number of U.S. units impacted:12,516 units

 

Arrow International

Device:Specific models of Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits

Recall reason:According to information on the FDA recall page, “the sheath body may separate from the sheath hub during the insertion procedure. This may cause significant bleeding . . . and an interruption of the inflating-deflating balloon therapy.”

When recall was initiated:February 10, 2016

Number of U.S. units impacted:13,405 units

 

Boston Scientific

Device: Certain lots of the Fetch 2 Aspiration Catheter, model number 109400-001.

Recall reason: According to information on the FDA recall page, “the catheter shaft may break at various points along the device . . . If breakage occurs while the device is in a patient, pieces of the catheter may block blood supply to the heart or blood vessels. This could result in the need for additional medical procedures, patient injury, or death.”

When recall was initiated: March 22, 2016

Number of U.S. units impacted: 17,455 units

 

HeartWare

Device: Batteries used for the HeartWare Ventricular Assist Device (HVAD) with serial numbers BAT000001 to BAT 199999, model number 1650.

Recall reason: According to information on the FDA recall page, “the batteries . . . may lose power prematerly due to faulty cells.” If another power source is not connected, “the pump will stop working and the patient may experience serious adverse health consequences, including death.”

When recall was initiated: January 7, 2016

Number of U.S. units impacted: 18,631 units

 

Hummingbird Med Devices

Device: ABG-HM-1 Hummi Micro-Draw Blood Transfer Device under lot numbers 15180, 15286, 15287, 15300, 15305

Recall reason: According to information on the FDA recall page, “the Y-shaped connector and the yellow tube may disconnect from each other prior to or during use. This could lead to blood or fluid leakage.”

When recall was initiated: October 1, 2015, recall listed in FDA database on May 26, 2016

Number of U.S. units impacted: 37,750 units

 

Alere

Device: Alere planned to take the INRatio and INRatio2 PT/INR Monitoring System, including INRatio Test Strips, off the market and to stop manufacturing the product.

Recall reason: According to information on the FDA recall page, “the INRatio System may generate an incorrect low result . . . If an incorrect low INR result is acted upon . . . the patient may be at risk of major or fatal bleeding.”

When recall was initiated: July 11, 2016

Number of U.S. units impacted: 125,576 units

 

Baxter

Device: All unexpired lots of the 50 mm 0.2 Micron Filter with product code H93835

Recall reason: According to information on the FDA recall page, the agency received “reports about the presence of particulate matter and the potential absence of filter membrane layers int eh filter set . . . [this] may contaminate a solution. This could result in bloodstream infections that may cause fever, septic shock, multiple organ dysfunction, and other serious adverse health consequences including death.”

When recall was initiated: August 24, 2016

Number of U.S. units impacted: 130,100 units

 

St. Jude Medical

Device: The Fortify, Unify, and Assura Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators

Recall reason: According to information on the FDA recall page, there were “reports of rapid battery failure caused by deposits of lithium . . . forming within the battery, and causing a short circuit. If the battery unexpectedly runs out before the patient is aware of the rapid battery drain and able to have it replace, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death.”

When recall was initiated: October 10, 2016

Number of U.S. units impacted: 251,346 units

 

Dexcom

Device: The Dexcom G4 PLATINUM REceiver, G4 PLATINUM (Pediatric) Receiver, G4 PLATINUM (Professional) Receiver, G4 PLATINUM Receiver with Share, G4 PLATINUM (Pediatric) Receiver with Share, G5 Mobile Receiver

Recall reason: According to information on the FDA recall page, “the audible alarm may not activate in the receiver piece when low or high glucose levels . . . are detected. Relying on this product for notification of low or high blood sugar could result in serious adverse consequences, including death as the auditory alarm may not sound and users might not be notified of low or high blood sugar.”

When recall was initiated: February 23, 2016

Number of U.S. units impacted: 263,520 units

 

Cook Medical

Device: Torcon NB Advantage Beacon Tip Catheters, Royal Flush Plus Beacon Tip High-Flow Catheters, Slip-Cath Beacon Tip Hydrophilic Catheters, Shuttle Select Slip-Cath Catheters. 

Recall reason: According to information on the FDA recall page, there were “complaints that the catheter tip may split or separate and could potentially enter the patient’s blood stream.” This could lead to serious injury or even death, and the device may not work.

When recall was initiated: Initiated July 2015 and expanded February 25, 2016

Number of U.S. units impacted: 408,011 units

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