Recall Z-2111-2023 ยท OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Abiomed, Inc.
Impella 2.5 intravascular micro axial blood pump, Product Number 005042
| Date | Jul 14, 2023 (initiated Jun 14, 2023) |
| Status | Open, Classified |
| Reason | There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility. |
| Root cause | Under Investigation by firm |
| Action | An URGENT: MEDICAL DEVICE CORRECTION (NOTIFICATION) dated 6/14/23 was sent to customers. RECOMMENDATIONS: Clinicians are cautioned to position the Impella system carefully in patients with TAVR, and to be aware of this potential interaction. In this situation, clinicians should avoid repositioning while the device is spinning and should turn the device to P0 during repositioning or any movement that could bring the outlet windows into proximity to the valve stent structures. If there is low flow observed in a patient implanted with a TAVR while on Impella heart pump support, you should consi |
| Quantity | 9252 units |
| Distribution | Worldwide distribution - US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.