Recall Z-1589-2026 ยท OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Abiomed, Inc.
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also inc
| Date | Mar 31, 2026 (initiated Feb 18, 2026) |
| Status | Open, Classified |
| Reason | Increased risk of purge leaks with Generation 1 purge cassettes. |
| Root cause | Device Design |
| Action | Abiomed notified consignees on about 02/18/2026 via UPS next day airmailed letter titled "URGENT MEDICAL DEVICE RECALL (REMOVAL)." Consignees were instructed to identify and quarantine any affected Purge Cassettes in inventory, utilize the provided return shipment label to initiate return of affected cassettes, and complete and return the business reply form provided. Abiomed will provide a credit memo for returned units. Consignees were also encouraged to follow their standard process when ordering their Generation 2 Purge Cassettes, forward the notification to anyone within the facility ne |
| Quantity | 33,107 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.