Johnson & Johnson's Abiomed Unit Recalls Instructions For Some Impella Blood Pumps Due To Cutting Risks

Zinger Key Points
  • FDA classifies the recall of Abiomed's blood pumps as the most serious as the use could cause serious injuries or death.
  • During operations, the Impella device could cut through the wall of the left ventricle.

On Thursday, Johnson & Johnson’s JNJ Abiomed said it is recalling its Impella Left Sided Blood Pumps because the pump catheter may perforate (cut) the wall of the left ventricle in the heart. 

During operations, the Impella device could cut through the wall of the left ventricle.

The 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. 

There have been 129 reported serious injuries, including 49 reports of death.

Impella Left Sided Blood Pumps are used for short-term support of the pumping chambers of the heart (ventricles) during high-risk catheter-based procedures called percutaneous coronary interventions (PCI). 

Impella Left Sided Blood Pumps are also used when there is an ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack (acute myocardial infarction), open-heart surgery, or when the heart is not functioning well due to a condition called cardiomyopathy. 

Impella therapy aims to reduce the work of the heart’s ventricles and support the circulatory system so the heart has time to recover. 

The recall is a correction, not a product removal, the FDA said, adding that the company had sent a correction letter to affected customers with new and revised warnings.

The medical device maker started the recall process on December 27, 2023, and has recalled 66,390 devices in the United States. The recalled devices were distributed between October 10, 2021, to October 10, 2023.

In 2022, Johnson & Johnson acquired Abiomed for an upfront payment of $380.00 per share in cash, corresponding to an enterprise value of approximately $16.6 billion

Price Action: JNJ shares are up 0.28% at $156.20 on the last check Thursday.

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