Recall Z-2602-2026 ยท DYB Introducer, Catheter
Abiomed, Inc.
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
| Date | Jun 25, 2026 (initiated May 22, 2026) |
| Status | Open, Classified |
| Reason | Potential for thrombus formation during prolonged use of the introducer. |
| Root cause | Under Investigation by firm |
| Action | Abiomed notified consignees on about 05/22/2026, via letter titled "URGENT MEDICAL DEVICE RECALL (REMOVAL)." Consignees were made aware of the issue and that if thrombus formation were to occur, the user may encounter difficulty aspirating the sheath sidearm or valve and may observe thrombus in the syringe or sidearm post aspiration or around the valve post CP pump removal. They were instructed to review inventory for affected units and quarantine them, arrange for their return using the provided shipment label from Sedgwick, and complete and return the provided business response form. Consign |
| Quantity | 7 units |
| Distribution | Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K241708 | Abiomed 14Fr Low Profile Introducer Kit Abiomed, Inc., Aug 6, 2024 |