Abiomed, Inc.: Introducer, Catheter
Recall Summary Abiomed is recalling the 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP heart pumps because blood clots may form inside the introducer during extended use. The product has been distributed nationwide in the United States and in Japan. This is a Class II recall, meaning there is a potential health risk but not an immediate life-threatening situation.
- Recalling firm
- Abiomed, Inc.
- Product
- Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
- Reason
- Potential for thrombus formation during prolonged use of the introducer.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-22
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/a167bea2-69e0-4594-87df-01401e34a367