Abiomed reports 129 serious injuries, including 49 deaths, related to the issue of potential cuts in the wall of the heart.
This recall (a correction and not a product removal) affects 66,390 Impella pumps in the U.S. That includes Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAsist and Impella LD.
Affected devices were distributed between Oct. 10, 2021, and Oct. 10, 2023, with Abiomed initiating the recall on Dec. 27, 2023.
Impella pumps provide short-term support for the ventricles during high-risk catheter-based percutaneous coronary interventions (PCIs). Uses also include for ongoing cardiogenic shock, open-heart surgery or cardiomyopathy. The therapy aims to reduce the work of the heart’s ventricles and support the circulatory system.
Abiomed recalled the left-sided blood pumps in this case due to the potential for catheter perforation, according to an FDA notice. The catheter may perforate, or cut, the wall of the left ventricle in the heart. This could lead to serious health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow and death.
The company’s urgent medical device correction letter, sent on Dec. 27, 2023, included new and revised warnings for customers. It included these updated warnings in the device’s instructions for use (IFU).
Abiomed instructed customers to carefully position the pump catheter during operative procedures. They should use imaging when advancing or torquing the pump catheter and use special care when inserting the pump catheter in patients with certain high-risk conditions or during active CPR.
Johnson & Johnson MedTech brought on the Impella heart pumps through its $16.6 billion acquisition of Abiomed in 2022. Since then, though, it’s faced a series of Impella heart pump recalls, culminating in an FDA warning letter last fall.
Statement from Abiomed
A company spokesperson issued the following statement from Abiomed regarding the latest recall:
We have updated our instructions for use (IFU) for our Impella system to further address the potential risk of a rare complication, left ventricular (LV) perforation. With patient safety top of mind, our IFU has been updated with stronger technical guidance around implantation and repositioning and emphasizes specific cardiac and peripheral vascular anatomic considerations when implanting Impella.
This notification is not a device removal and Impella heart pumps remain on the market and available for patients.
