Dive Brief:
- Johnson & Johnson subsidiary Abiomed recalled its Impella left sided blood pumps for risk that the devices could perforate the heart during a procedure. The recall began on Dec. 27 with Abiomed updating its instructions for use.
- The Food and Drug Administration identified the recall as a Class I event, the most serious type of recall, in a Thursday notice. The agency has received 129 reports of serious injuries, including 49 deaths, related to the problem.
- Abiomed’s Impella heart pumps, which are used to support the heart during procedures or during cardiogenic shock, were the subject of four Class I recalls last year, including the latest recall. The company also received an FDA warning letter for quality problems with Impella and software used in the device that had not been authorized by the agency.
Dive Insight:
Abiomed recalled the Impella pumps because of the risk that the catheter may cut through the wall of the left ventricle. Use of the affected pumps could result in perforation or free wall rupture, hypertension, lack of blood flow and death, the FDA said in the notice.
Abiomed’s latest recall encompasses more than 66,000 devices distributed in the U.S. between October 2021 and October 2023. The models affected by the recall include the Impella 2.5, Impella CP, Impella 5.0, Impella 5.5, and Impella LD.
More than 26,000 recalled devices were distributed outside of the U.S., according to a database entry.
Abiomed updated its instructions for use with updated warnings, including to use imaging when advancing or torquing the pump catheter, and to use special care when inserting the pump catheter in patients with certain high-risk conditions or during CPR.
An Abiomed spokesperson wrote in an email that the instructions were updated with stronger technical guidance around implantation and repositioning, emphasizing specific cardiac and peripheral vascular anatomic considerations.
In response to questions about whether Abiomed plans to pause use of the device, the spokesperson said “this notification is not a device removal and Impella heart pumps remain on the market and available for patients.”
Abiomed has flagged other problems with its Impella pumps in the past year. In June 2023, the company recalled some of its Impella RP Flex pumps, citing a higher-than-expected rate of blood clots. The company also warned that month about potential interactions between the company’s heart pumps and transcatheter aortic valve replacement stents, with the FDA receiving four reports of death related to the problem.
Meanwhile, an April 2023 recall flagged a higher rate of purge leaks in the Impella 5.5 pump with SmartAssist.
The FDA sent a warning letter to Abiomed in September, citing findings from an inspection that took place between March and April 2023. The agency found Abiomed waited until the inspection to issue a recall of its Impella 5.5 pumps related to the fluid leaks, despite an “unacceptable elevated rate” of complaints. The letter also cited cases where Abiomed had waited until the inspection to send medical device reports to the agency that the company had known about years prior.
The agency also said Abiomed incorporated software in Impella pumps that should be regulated as a medical device but had not been authorized by the FDA. The Impella Connect software was designed to let users remotely monitor the performance of pumps, view case information and filter notifications by alarm status.
The Abiomed spokesperson said the company is working with the FDA to fully resolve the observations as quickly as possible.
J&J acquired Abiomed for $16.6 billion in 2022.