Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

Device manufacturer Abiomed has recalled the labeling for various models of its left-sided heart pumps due to the potential for the pump catheter to perforate the left ventricle’s wall, the US Food and Drug Administration announced Thursday.

Importantly, “this recall is a correction, not a product removal,” the announcement stressed, though the FDA still categorized it as a Class I recall, the most serious type. Abiomed sent out an Urgent Medical Device Correction on December 27, 2023, alerting customers about the issue.

According to the FDA, “use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death.” So far there have been 129 reported serious injuries, including 49 reports of death, they said.

Fully 66,390 devices distributed over 2 years are affected, including the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD.

In its letter, Abiomed cautioned clinicians to carefully position the pump catheter during cases, to use imaging when advancing or torquing the catheter, and to be particularly alert when using the devices in patients with certain high-risk conditions or during active CPR. Additionally, they should review updated warnings in the products’ Instructions for Use and spread the word about the recall among colleagues, the company said.

Abiomed, in a company statement, highlighted to TCTMD that the updated IFU “address the potential risk of a rare complication,” namely LV perforation. The new wording offers “stronger technical guidance around implantation and repositioning and emphasizes specific cardiac and peripheral vascular anatomic considerations when implanting Impella,” the statement said. “This notification is not a device removal and Impella heart pumps remain on the market and available for patients.”

The move follows several by the FDA towards Abiomed, now part of Johnson & Johnson, in the past year.

In October 2023, the agency announced it had sent a warning letter to Abiomed that specified the company should have obtained premarket approval for its Impella Connect system before making the product’s software available to users. The FDA, more broadly, has begun cracking down on clinical decision support software, novel tools that are being increasingly used in healthcare settings.

Prior to this, in June 2023, Abiomed recalled the labeling for catheters used in its Impella RP Flex with SmartAssist System and issued a “device correction” for all types of its Impella left-sided mechanical circulatory support devices because the pumps’ labeling didn’t fully address the precautions needed when treating patients who have undergone TAVI. In April 2023, Abiomed recalled some of its Impella 5.5 with SmartAssist devices in response to complaints about purge fluid leaking from the purge sidearm of the pump. All three were designated Class I recalls by the FDA.