Abiomed 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.
Over 66,000 of these medical devices that were distributed between October 2021 and October 2023 are affected.
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 also are used when there is 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 provide support for the circulatory system so the heart has time to recover. There are several types of Impella pumps that are used for different therapeutic reasons.
On December 27, 2023, Abiomed sent all affected customers an Urgent Medical Device Correction letter.
The letter requested customers to adhere to new and revised warnings:
- Carefully position the pump catheter during operative procedures
- Use imaging when advancing or torquing the pump catheter
- Use special care when inserting the pump catheter in patients with certain high risk conditions or during active CPR
- Review the updated warnings in the device Instructions for Use
- Notify everyone at your facility who needs to be informed of this recall correction
- Notify any other facilities where the products have been forwarded of the updated Instructions for Use
People who may be affected include:
People who are undergoing procedures with the Impella Left Sided Blood Pumps.
People who have anterior infarction (heart disease).
Elderly people and women.
The FDA states on its website: “Please be aware, this recall is a correction, not a product removal. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.“
Based in Danvers, Massachusetts, USA, Abiomed, Inc., part of Johnson & Johnson MedTech, is a leading provider of medical technology that provides circulatory support and oxygenation. Its products are designed to enable the heart to rest and recover by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure.
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