Six More Deaths Trigger an Additional Class I Recall for Medtronic’s HeartWare HVAD Ventricular Assist Devices
WASHINGTON, DC – A news report published on medtechdive.com states that the U.S. Food and Drug Administration has categorized another group of recalls concerning Medtronic’s HeartWare HVAD Ventricular Assist Device as a Class I recall after the agency received reports of fatalities connected to the medical device. The FDA recall notice states that this recall affects approximately 106,360 HeartWare HVAD adapters, controllers, cables, batteries, and monitors that were sold nationwide. All of the recalls are related to the same problem.
The U.S. Food and Drug Administration has now classified thirteen HeartWare recalls as Class I recalls in the past year. The medical device has had a substantial number of fault reports and is implicated in at least six patient deaths.
Medtronic has provided the same reason for these Class I recalls. According to Medtronic, the medical device components have a defect involving the Controller power cables (Adapter, DC Adapter, and Battery cables), HVAD Monitor data cables, and the HVAD Alarm Adapter to cause damage to the HVAD Controller ports during insertion of the cables into the Controller ports causing “wear from misalignment of the cables to the port.”
The FDA’s recall notice contains no further information, but other regulators from foreign countries, such as the Danish Medicines Agency, have forwarded the letter Medtronic sent to their healthcare professionals concerning the problems to the U.S. FDA.
In the Medtronic letter, the company warns of damage caused by cable misalignment and how the device’s ports might make it impossible for the connectors to lock to the HVAD controller. Should this occur, power can be interrupted or disconnected, causing the HVAD pump to stop interacting with the monitor. The letter states that the controller may need to be exchanged to restore connections in that situation.
Medtronic has received 855 complaints about the issue regarding its second-generation controller. Some of the customer complaints have linked patient deaths to the problem. Medtronic has reported that it has identified one death related to reconnecting the power cables to the controller. Another seven deaths reported were linked to “complications from a controller exchange where bent pins were observed on a controller port [and] three deaths unrelated to this issue, but where bent pins were observed on a controller data port,” Medtronic stated in its letter.
Medtronic has also received another six reports of “harms ranging from minor cardiac arrhythmias and anxiety to hospitalization and cardiac arrest” in circumstances where it was needed to exchange the HVAD controller.
Medtronic said that the company is redesigning the cables to reduce the risk of the issue. However, Medtronic is urging healthcare professionals to look for damaged connector plugs and cables, and patients are advised to examine their devices at least once a week.
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