CI’s Key Takeaways: 

  • Abiomed has issued a recall for its Impella Left Sided Blood Pumps due to the potential risk of left ventricle perforation in the heart, with 49 reported deaths and 129 serious injuries linked to the use of the affected pumps.
  • The FDA has classified this recall as a Class I recall, which is the most serious type, indicating a significant risk of serious adverse health consequences or death associated with the use of the product.
  • Abiomed has sent an Urgent Medical Device Correction letter to all affected customers, advising them to adhere to new and revised warnings and precautions when using the Impella Left Sided Blood Pumps, including careful positioning of the pump catheter, use of imaging during procedures, and special care for patients with certain high-risk conditions.

Abiomed is recalling its Impella Left Sided Blood Pumps because the pump catheter may perforate 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. The FDA has identified this as a Class I recall, the most serious type of recall.

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

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

Recalled product

  • US available product names: Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, Impella LD
  • Product codes: See recall database entry
  • Distribution dates: Oct 10, 2021 to Oct 10, 2023
  • Devices recalled in the US: 66,390
  • Date Initiated by Firm: Dec 27, 2023

Who May be Affected

  • People who are undergoing procedures with the Impella Left Sided Blood Pumps
  • People who have anterior infarction (heart disease)
  • Elderly people and women

What to Do

On Dec 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

Customers in the US with questions about this recall should contact Abiomed Inc at 978-646-1400.