Dive Brief:
- Johnson & Johnson has recalled certain automated controllers for its Impella heart pumps over a fault linked to five serious injuries, the Food and Drug Administration said Tuesday.
- The company’s Abiomed unit told customers to return the affected devices when contacted by its field servicing team because of potentially fatal purge pressure issues. Abiomed will make a design change during device servicing to correct the problem. Hospital inventory can continue to be used, according to the FDA’s alert.
- J&J’s recall, which triggered an FDA early alert, follows other recent safety actions to address two problems with Impella that were collectively linked to four deaths.
Dive Insight:
The recalled devices serve as the primary user control interface for Impella catheters. Using the devices, healthcare professionals can control the heart pump as it provides circulatory support and monitor the catheter for alarms. Collectively, the devices enable physicians to reduce the work of the left ventricle to give the heart time to recover.
Abiomed wrote to customers last week after identifying purge pressure issues. The company found that the force users apply when inserting and removing purge discs contributes to purge retainer failures such as cracks. Impella features a purge system to stop blood from getting into the device’s motor.
“Failures impacting purge pressure and detection of the purge disc may lead to errors, alarms and potential interruptions in hemodynamic support when the Automated Impella Controller may need to be replaced,” the FDA said in its early alert. “Purge retainer failures may result in a pump stop with resultant loss of hemodynamic support.”
The loss of support for the heart poses a serious risk to patient health and may lead to permanent impairment or death, the FDA said. As of Aug. 27, Abiomed had reported five serious injuries and no deaths associated with the issue.
J&J said in an emailed statement that the company initiated the recall after identifying a necessary design change for certain Automated Impella Controllers, which requires adding one screw to the purge retainer.
“A review of 660 complaints from February 2022 to July 2024 showed a 0.61% occurrence rate related to a purge retainer failure,” a spokesperson wrote. “The additional screw addresses this issue, and the design change has already been completed in 91% of AICs globally. ”
Abiomed’s recall is the third safety action related to Impella in quick succession. The FDA published an early alert about the potential for Abiomed’s controllers to fail to detect a pump when connected in July. That fault was linked to three deaths. The agency posted another Impella early alert in August. That notice described a pump driver circuit assembly problem that was linked to one death.
