J&J’s Abiomed Recalls Impella Left-Sided Heart Pumps for Perforation Risk

The U.S. Food and Drug Administration has identified J&J MedTech company Abiomed’s December 27, 2023 recall of its Impella left-sided blood pumps as Class I.
 
Abiomed is recalling the products because the pump catheter may perforate the wall of the heart’s left ventricle. During operations, the Impella device could cut through this wall.
 
Using the Impella pumps could cause left ventricle perforation of free wall rupture, hypertension, lack of blood flow, or death. There have thus far been reports of 129 serious injuries and 49 deaths related to the issue.
 
The FDA advised that this is a correction, not a product removal.
 
Abiomed urged customers to carefully position the pump catheter during procedures and use imaging when advancing or torquing the pump catheter. Special care should be used when inserting the catheter in patients with certain high-risk conditions or during active CPR. The company also advised reviewing the updated warnings in the device’s Instructions for Use.

In a statement, Abiomed said, “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.”
 
Impella left-sided blood pumps are used for short-term support of pumping the ventricles during percutaneous coronary interventions (PCI). The pumps are also used when there’s ongoing cardiogenic shock that happens less than 48 hours after an acute myocardial infarction, open-heart surgery, or during episodes of cardiomyopathy.
 
The therapy aims to lower the work of the ventricles and offer support for the circulatory system, so the heart has time to recover. There are several types of Impella pumps used for a variety of therapeutic reasons.
 
Last year, the company’s Impella RP Flex with SmartAssist catheter were recalled. J&J offered comment on that recall in a statement to MPO.