Dive Brief:
- Abbott is recalling thousands of Heartmate II and Heartmate 3 left ventricular assist systems because biological material can build up and obstruct the devices, making them less effective at pumping blood, the Food and Drug Administration said Monday.
- Reports of 273 injuries and 14 deaths have been linked to the problem, with the material typically taking two or more years to accumulate, according to the recall notice. The FDA identified the action as a Class I recall, the most serious type.
- Heartmate devices are used to support patients with severe left ventricular heart failure who are awaiting a heart transplant, or the device can be permanently implanted when a transplant isn’t an option. In February, Abbott told customers in an urgent correction letter there is no need to return any products to the company.
Dive Insight:
Heartmate devices take over the pumping function of the left ventricle, the heart’s main pumping chamber, when it is weakened, propelling blood into the aorta to help it circulate through the body.
The company has recalled 13,883 devices in the U.S., distributed since April 21, 2008.
The issue at the center of the recall occurs when biological material accumulates between the Heartmate outflow graft and the outflow graft bend relief or other components added during surgery, the FDA said. Called extrinsic outflow graft obstruction, the buildup can trigger alarms that indicate low blood flow and may prevent the pump from adequately supporting the heart.
Abbott’s letter asked customers to pay attention to low flow alarms as the first symptom of significant outflow obstruction. It also provided guidance on how to diagnose unresolved low flow associated with outflow graft obstruction.
The letter advises clinicians that if a patient’s symptoms persist, it is important to rule out compression of the outflow graft through imaging. Upon diagnosing outflow graft obstruction, treatment options include patient monitoring, percutaneous intervention such as outflow graft stenting, surgical decompression by opening the bend relief, or pump replacement.
Abbott said it is developing a design solution to minimize the accumulation of biodebris on the outflow graft and will implement it upon receiving regulatory approvals. The solution is intended only for Heartmate 3 outflow grafts because Heartmate II devices are being discontinued, the company said.
The company asked customers to complete and return an acknowledgment form and said it would continue to send letters until the corrective measures are in place.
Abbott acquired the Heartmate left ventricular assist device through the acquisition of St. Jude Medical, completed in 2017. St. Jude gained the technology when it bought Thoratec in 2015.
Abbott became the only supplier of left ventricular assist devices in the U.S. after Medtronic pulled its Heartware pump from the market in June 2021 following a series of recalls. The FDA advised healthcare providers to stop implanting Heartware devices and to use Abbott’s Heartmate 3 as an alternative.
Last month, Abbott recalled a communication system that monitors patients implanted with the Heartmate 3 due to a risk that the system could cause the pump to stop or start unintentionally. The event was labeled a Class I recall and did not require product removal.