Recall Z-2319-2024 ยท OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Abiomed, Inc.
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
| Date | Jul 17, 2024 (initiated May 31, 2024) |
| Status | Open, Classified |
| Reason | Nine (9) Impella CP pumps failed inspection and were inadvertently released. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | On May 31, 2024 consignees were contacted by phone with a script followed-up by sending URGENT VOLUNTARY MEDICAL DEVICE RECALL (REMOVAL) letters to consignees. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER: 1.Examine your inventory immediately to determine if you have product subject to this recall(removal). QUARANTINE AND DO NOT USE THE SUBJECT PRODUCTS. 2.Your Abiomed Representatives have been provided instructions to support facilitation of locating, separating, and returning affected product for replacement. Work with your Abiomed Representative toreview, complete all fields, and sign the Busin |
| Quantity | 9 units |
| Distribution | Domestic only: FL, MA, OH TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.