Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25
FDA device recall Z-2602-2026 · posted 2026-06-25 · Open, Classified
Recall details
- Recalling firm
- Abiomed, Inc.
- Reason for recall
- Potential for thrombus formation during prolonged use of the introducer.
- Action taken
- 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. Consignees were also instructed to forward the notification to anyone in the facility that needs to be informed, if any of the subject products have been forwarded to another facility, contact that facility and provide them with the notification, and to post a copy of the notification in a visible area for awareness.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DYB
- Quantity affected
- 7 units
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
- Date initiated
- 2026-05-22
- Date posted
- 2026-06-25
- Location
- Danvers, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Abiomed 14Fr Low Profile Introducer Kit (K241708) | Abiomed, Inc. | 2024-08-06 |