Medical Device Recalls Not Slowing Down: Here Are Some of the Biggest From 2016

Featured article by Cher Zavala, Independent Technology Author

While healthcare technology continues to help facilities move ahead in leaps and bounds, and medical devices save lives by the millions every year and make life more comfortable for many patients, there are certain risks to keep in mind too.

In particular, in recent times it seems like more medical devices than ever have been recalled by the FDA. That is because, in fact, according to a 2016 third-quarter report from the Stericycle ExpertSolutions Recall Index, recalls rose in that quarter, and the number happened to be the highest observed since the year 2000.

While this rise likely has a lot to do with the fact that the FDA is more stringent than ever, and that more and more devices are being created thanks to technological and medical advancements, it’s still something that healthcare managers need to be aware of and prepare for. After all, even the largest manufacturers can have products recalled.

If you want to reduce the risk that your facility will face expensive lawsuits when patients or families affected by faulty devices hire a personal injury attorney to represent them, you must continually stay up to date on the latest recalls and relevant news. You also need processes in place to deal with them. Read on for just a taste of some of the biggest device recalls from last year that affected facilities and patients nationwide.

HeartWare’s Ventricular Assist Device and Batteries

HeartWare Inc. issued multiple recalls related to their HeartWare Ventricular Assist Device (HVAD) in 2016. The product was created to help move blood from the heart to the rest of the body in users, and is primarily utilized by patients who are waiting for a heart transplant and facing death because of end-stage left ventricular heart failure. The HVAD has a pump that’s inserted around the pericardium, as well as a controller that is used to change the speed and function of the pump.

The largest recall by far, and the first in the year, happened when HeartWare issued a notice about problems with the batteries used in the device with the model number 1650. The company recalled the batteries in faulty products which were created and distributed between May and July in 2015. All in all, over 18,500 units were recalled across the country.

This HeartWare recall was a Class I notice, the most serious type possible, since the use of the faulty product could have caused serious injury or death in patients. In the devices with an issue, the batteries sometimes lost power prematurely, something which was attributed to faulty cells. Patients could, unfortunately, suffer from very serious health problems or even die if the batteries failed, because this meant that the HVAD system wasn’t connected to an additional power source and the pump could stop working.

HeartWare Inc. also had to recall the HVAD products for two other reasons in 2016, and both times the FDA classified the recalls as the most serious Class I. Later in the year, the controller was recalled due to an issue with a loose power connector, which could have caused the back portion of the pump’s driveline connector to become separated from the front. If this happened, there was the possibility that moisture could enter the controller and cause corrosion, connection failures (which could stop the pump altogether), electrical issues, and reduced speaker volume (which could mean patients wouldn’t hear the alarm the machine would sound).

At the same time, HeartWare Inc. also recalled the HVAD pumps because of a design flaw with the driveline connector (the tube that connects the pump to the external controller and power source). It was found that contamination of this driveline could have resulted in fluid or other material entering the HVAD’s pump. If this happened, the pump could have stopped or experienced electrical issues. Again, severe adverse health consequences, and death, were risk factors.

Cook Medical’s Catheter Sets & Trays

Another major recall in 2016 was issued by Cook Medical, in January. The firm had to recall its Single Lumen Central Venous Catheter Sets & Trays, as well as its Single Lumen Pressure Monitoring Sets & Trays, Femoral Artery Pressure Monitoring Catheter Sets & Trays, and Radial Artery Pressure Monitoring Catheter Sets and Trays all at once.

The various catheter sets and trays are designed to monitor the pressure in a patient’s artery or vein, to sample their blood, or to administer drugs and fluids. There were more than 12,500 products recalled, and they were all manufactured and distributed between April and October in 2015. Like the HeartWare recalls, this was identified as a Class I, and could have caused death or serious injury.

The issue with the faulty products was that the tips of the catheters occasionally separated or split away, due to a product-assembly error during the manufacturing process. If these tips did break away, they could enter a patient’s blood stream. This, in turn, could have necessitated medical intervention to retrieve them, as well as potentially causing serious harm or even death to patients. Furthermore, the faulty tips could have also made the catheters stop working.

A little later in the year, Cook Medical had to issue another major recall of their catheters. The healthcare company voluntarily recalled all of its catheter products (millions of units around the world) which had Beacon Tip technology. Cook had received further complaints about the tips of the catheters fracturing or splitting during medical procedures, and it seemed that the nylon material on them was susceptible to degradation. It was believed this was perhaps due to the environment of the storage units where they were being kept.