Abiomed, Inc.: Introducer, Catheter
Recall Summary Abiomed is recalling certain Impella CP Set introducers (product codes 1000413 and 1000834) distributed nationwide and in Japan due to a risk of blood clot formation during extended use. This Class II recall affects the 14Fr Low Profile Introducer Kits included in the 10th Generation Impella CP Set with SmartAssist. Healthcare facilities and patients who received these devices should contact Abiomed for further information.
- Recalling firm
- Abiomed, Inc.
- Product
- Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
- 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/1a085823-2387-4d5d-b63c-86c53574fd4d