A Class I recall is the federal watchdog’s most serious class of recall, indicating the potential for serious injury or death.
The HeartMate 3 devices are being recalled due to a malfunction in the outflow graft assembly which could cause the outflow graft to twist and occlude over time, which could result in a stalled pump flow and a persistent low flow alarm in the system, the FDA said.
The recall action is intended to update labeling and instructions for use for the device, Abbott clarified, and no units are being physically recalled.
A reduction in pumping can lead to serious adverse events, the agency warned, including blood clots and death.
The recall affects a total of 4,878 units in the US with catalog numbers 106524US, 106524 and 10652INT. The recall affects all lot numbers and all manufacturing dates for devices distributed between September 2, 2014 through to today, according to the FDA’s recall notice.
The FDA suggested that patients experiencing a persistent low flow alarm should contact the physician managing their HeartMate 3 system immediately. Abbott said that it is not recommending the devices be removed due to the issue.
Abbott began notifying patients of the issue as early as April, and provided updated guidelines for physicians implanting such devices and for patients currently implanted with the device.
The instructions included an additional LVAD surveillance echo exam at approximately two weeks after device implantation or before index hospitalization discharge and continued surveillance trans thoracic echo procedures at 1, 3, 6 and 12 months post-implantation.
Abbott initially released information on outflow graft twisting issues earlier this month after having received 32 reports of related issues.