Dive Brief:
- Johnson & Johnson’s Abiomed has asked customers to quarantine certain Impella devices over a risk linked to four serious injuries, the Food and Drug Administration said Wednesday.
- Abiomed wrote to customers last week after identifying a problem with the first-generation heart pump purge cassettes, which deliver rinsing fluid to the Impella catheter.
- The cassettes have an increased risk of purge leaks. Because the leaks can cause pumps to stop, Abiomed is removing the products in markets where its second-generation cassette is available.
Dive Insight:
Purge cassettes deliver fluid to create pressure, stopping blood from entering the heart pump’s motor. When a leak happens, purge pressure can drop and allow blood to enter the motor. If that happens, the pump may stop, potentially leading to the loss of hemodynamic support. As of Feb. 3, Abiomed had no reports of deaths linked to the issue, but the FDA said patients could die if their pumps stop.
Abiomed has asked buyers of its purge cassettes and an Impella RP pump set to check their stocks for the affected devices. Customers should remove all first-generation purge cassettes from use and return them to Abiomed.
When no second-generation devices are available, healthcare providers can use a purge cassette if absolutely necessary. Providers using first-generation devices should ensure increased monitoring of the purge system and refer to the instructions for use if a low-pressure alarm is triggered. Use of a purge cassette is always required with Impella pumps.
The FDA shared details of Abiomed’s letter in an early alert, the agency’s mechanism for providing timely information about potentially high-risk device issues. A formal recall notice can follow the publication of an early alert.
Impella devices have been the subjects of a series of Abiomed letters and FDA early alerts and recall notices. In January, Abiomed sent an urgent medical device correction about a malfunction risk linked to 22 reports of serious injuries.
