Abiomed, Inc.: Introducer, Catheter
Recall Summary Abiomed is recalling certain 14Fr Low Profile Introducer Kits (13 and 25 cm) used with the Impella CP Set with SmartAssist (10th Generation) due to the potential for blood clots to form during prolonged use. The affected products were distributed nationwide in the US and in Japan. This is a Class II recall, meaning the product could cause serious health problems or failure but is not expected to cause death.
- Recalling firm
- Abiomed, Inc.
- Product
- Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
- 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/b63f6eb6-2b96-4d3c-aa1d-f29d0c7d863c