Abiomed, Inc.: Introducer, Catheter
Recall Summary Abiomed is recalling certain 14 Fr x 25 cm Low Profile Introducer Kits used with Impella CP heart pump devices because blood clots may form inside the introducer during extended use. The recall affects units distributed nationwide in the US and in Japan. Healthcare facilities that received these introducers should check their inventory against the product codes listed (1000435).
- Recalling firm
- Abiomed, Inc.
- Product
- Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
- 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/7f0bf5c0-620f-4fcf-99a2-d9aadbd20276