The recall — which Medtronic initiated on Feb. 26 and FDA designated as Class I — is related to 855 complaints and eight reports of injuries, according to the FDA. Medtronic said today that the FDA’s figures are inaccurate.
The HVAD pump helps the heart continue to pump blood to the rest of the body, providing a bridge to cardiac transplants among people at risk of death from end-stage left ventricular heart failure. HVADs can also support heart tissue recovery and provide a destination therapy when there are no plans for new transplants.
The latest recall involves battery cables, data cables, adapter cables and controller 2.0 ports for HeartWare, according to FDA. Wear and tear of the connector plugs (power sources, data cable, and alarm adapter) can damage the controller port metal pins, preventing connection of power cables and data cables and causing a full or partial stop of the pump.
Medtronic disputed the FDA’s accounting of deaths and injuries. The company reported one death due to this issue and seven deaths potentially related to this issue, company spokesperson Kathleen Janascz said in the email to MassDevice.
“Three reported deaths were unrelated to this issue, but bent pins were observed. Six cases were observed where a controller exchange was performed and patient harms ranging from minor cardiac arrhythmias and anxiety to hospitalization and cardiac arrest. No patient harm was observed in the remaining 838 cases, including 817 cases where a controller exchange was performed with no long-term patient effects,” she added.
The FDA’s report of 12 deaths comes more than a month after the agency found another HVAD recall involving restart problems to be serious, with two deaths reported at the time.
Medtronic sent an Urgent Medical Device Notice to all affected customers on Feb. 26 with a host of guidelines and recommendations to promote better inspection and care of the connector pins among health providers and their patients.