In back-to-back announcements Thursday, the FDA handed down Class I ratings to recent recalls from Medtronic and Baxter International, identifying that the safety issues carry a high risk of serious injury or death.
Medtronic received the classification for the latest in a long string of flaws discovered within the HeartWare Ventricular Assist Device (HVAD) system, which was finally discontinued last year after racking up more than a decade’s worth of patient complaints and subsequent recalls—but remains implanted in around 4,000 people.
Baxter, meanwhile, saw the Class I designation as an upgrade to an urgent medical device correction that it issued earlier this month for the Volara system that connects to a ventilator to help expand the lungs and clear out mucus.
Though relatively small recalls—in total, they cover fewer than 700 devices distributed in the U.S. between the two companies—the issues have been linked to three deaths following technological malfunctions.
Before being discontinued just over a year ago, Medtronic’s HeartWare device was regularly implanted in patients with severe heart failure to help pump blood from the heart to the rest of the body. It was indicated both as a stopgap measure as patients awaited heart transplants and as a long-term alternative for those not eligible for transplant.
Since taking it off the market, Medtronic has continued to identify issues with the remaining HVAD systems—which weren’t recommended for removal since the risks of that procedure may outweigh those of the device’s own potential malfunctions. At the end of April, for example, it began a recall of more than 1,600 implant kits due to a welding defect that could allow moisture to corrode the inner workings of the pump.
The latest recall began in early May. It covers one lot of batteries for the heart pumps, totaling 429 batteries distributed in the U.S. during the three-month period between April 20 and July 19 of last year.
Once again, a welding defect is to blame for the issue. This time around, Medtronic spotted inadequate welding between the two cell battery packs that are used to power the HeartWare systems. If the packs separate, the battery may malfunction, leaving it unable to provide power to the system or to fully or properly recharge, which could lead to a sudden power failure. Though the malfunction will trigger an alarm, healthcare providers will be able to resolve the alarm without fully rectifying the battery issue, meaning the issues could continue.
So far, Medtronic has received two complaints related to the recall, one of which resulted in a patient’s death. In a letter (PDF) to healthcare providers, the company said it has taken actions “to improve control of the welding process” and is also replacing all affected batteries with new ones.
Baxter initiated its recall shortly before Medtronic’s, at the end of April. It affects 268 Volara systems distributed in the U.S. between the end of May 2020 and mid-April of this year, a week before the recall began.
Baxter inherited the Volara system in its acquisition of Hillrom, which was completed for $10.5 billion in December. The device provides a trio of respiratory therapies that expand the lungs, clear them of mucus and either treat or prevent a partial collapsed lung.
However, the company found that in some cases, when the system is connected to an in-line ventilator during at-home use, patients may not receive enough oxygen from the ventilator. That could occur due to improper training for at-home caregivers, which may lead them to improperly connect the Volara system to the ventilator and leave them unprepared to handle that or any other issues that may arise while the device is being used.
In those cases, a lack of oxygen or incomplete treatment from the Volara device could cause a patient to choke on mucus, develop pneumonia that could in turn lead to respiratory failure, experience a brain injury or even die. To date, Baxter has received one complaint related to the recall plus reports of one injury and two deaths.
The company said patients can continue to use the system in their homes but recommended that caregivers keep a close eye out for signs of respiratory distress and use a prescribed suction unit to help remove mucus and other airway secretions.