Abiomed Impella ‘Instruction for Use’ Recall Linked to 49 Deaths

After a 2023 marred by recalls and FDA wrath, Johnson & Johnson subsidiary Abiomed has once again issued a recall connected to its Impella blood pumps. Categorized as Class I, the most recent recall includes the Impella Left Sided Blood Pumps due to the risk of the pump catheter perforating the wall of the left ventricle in the heart. Of note, the recall relates to the Impella’s instructions for use, not the devices themselves, an Abiomed representative told MD+DI. Additionally, the recall is considered a correction, not a product removal.

“This notification is not a device removal and Impella heart pumps remain on the market and available for patients,” according to the company.

Impella Left Sided Blood Pumps are used for short term ventricle support during percutaneous coronary interventions, cardiogenic shock, or cardiomyopathy. Improper handling of Impella pumps, according to the company, may cause serious health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death.

On December 27, 2023, Abiomed sent customers an Urgent Medical Device Correction Letter requesting that all affected adhere to new and revised instructions for use warnings. Those updates included:

“We have updated our instructions for use for our Impella system to further address the potential risk of a rare complication, left ventricular perforation,” an Abiomed representative told MD+DI. “With patient safety top of mind, our instructions for use has been updated with stronger technical guidance around implantation and repositioning and emphasizes specific cardiac and peripheral vascular anatomic considerations when implanting Impella.”

The devices included in the recall are the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD. Over 66,300 devices have been recalled in the US that were distributed between October 2021, and October 2023. More than 26,000 recalled devices were distributed outside of the US, according to a database entry.

There have been 129 reported serious injuries, including 49 deaths connected to the recall.

This is not the company’s first foray into recalls for its Impella devices. In 2023, Abiomed was hit with four Class I recalls, including this one, for its Impella devices. In April, the company recalled some of its Impella 5.5 with SmartAssist systems after receiving complaints from customers reporting purge fluid leaking from the purge sidearm of the pump. In June, its Impella RP Flex pumps were recalled after the company reported a higher-than-expected blood clot rate. Around the same time, Abiomed also warned of the potential interaction between the heart pumps and transcatheter aortic valve replacement stents, stating that, for patients who also have a TAVR implant, the stentlike struts along the outer edges of the device have a risk of connecting with Impella’s spinning impeller, which can shear the blades and cause parts of the pump to fracture. The collision may result in a dangerous loss of blood flow through the damaged Impella device and spread debris into the bloodstream. The recall was later updated to include four deaths.

Outside of recalls, Abiomed was also in the crosshairs of FDA after it sent a warning letter to the company citing finding from a spring 2023 inspection which allegedly found that the company had waited until the inspection to issue a recall of its Impella 5.5 pumps related to purge fluid leaks, despite an “unacceptable elevated rate” of reports. The warning letter also said the company had waited until the inspection to send the agency medical device reports which the company had known about years prior to informing FDA.

The agency also wrote that Abiomed was incorporating unregulated software into its Impella pumps. This software, according to FDA needed to be regulated as a medical device and authorized by the agency. This specific guidance related to the software has since drawn criticism from some industry experts, including two citizen petitions.