Recall Z-2602-2026
Abiomed, Inc. · initiated May 22, 2026
Class I – dangerous or defective products that could cause serious health problems or death
Product
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Codes / lots: Impella Set Product Code: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530.
Reason for recall
Potential for thrombus formation during prolonged use of the introducer.
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-2602-2026
- Initiated
- May 22, 2026
- Posted by FDA
- June 25, 2026
- Product code
- DYB – Introducer, Catheter
- Quantity
- 7 units
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
- Recalling firm
- Abiomed, Inc., Danvers, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2599-2026 Class I | Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product…Potential for thrombus formation during prolonged use of the introducer. | 05/22/2026Open, Classified |
| Z-2600-2026 Class I | Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product…Potential for thrombus formation during prolonged use of the introducer. | 05/22/2026Open, Classified |
| Z-2601-2026 Class I | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low…Potential for thrombus formation during prolonged use of the introducer. | 05/22/2026Open, Classified |