Impella Cardiac Support Catheters: Risk of Left Ventricle Perforation
Impella cardiac catheters are being recalled due to risk of left ventricle perforation during operator use. The FDA has classified this Class I recall affecting 91,914 units worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4 per the rubric. No deaths or reported serious injuries are mentioned in the source; the recall addresses a potential hazard through preventative updated guidance in the Instructions for Use.
Plain-English summary
Abiomed is recalling multiple models of the Impella intravascular micro axial blood pump, a device used to provide mechanical support to the patient's circulatory system. The recall affects 91,914 units—65,857 in the United States and 26,075 distributed internationally to Australia, Canada, Germany, France, India, Mexico, Taiwan, and the US Virgin Islands.
The FDA classified this as a Class I recall because the pump inlet can perforate the left ventricle wall during operation due to operator handling. In response, Abiomed has updated the Instructions for Use to include warnings about this risk and guidance on proper handling procedures.
Clinicians and healthcare facilities using these devices should review the updated Instructions for Use immediately. Contact Abiomed or the FDA for additional information on the safety update.
The recalled product
- Product
- Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 wit
- Manufacturer
- Abiomed, Inc.
- Hazard
- cardiac-perforation
- operator-error
Distribution
Distributed nationwide across the United States.
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