Recall Z-1590-2023 ยท OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Abiomed, Inc.
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
| Date | May 18, 2023 (initiated Apr 17, 2023) |
| Status | Open, Classified |
| Reason | The Impella 5.5 pump experienced a heightened complaint rate for purge leaks. |
| Root cause | Device Design |
| Action | An URGENT MEDICAL DEVICE RECALL (REMOVAL) notification letter dated 4/17/23 was sent to customers. ACTIONS RELATED TO THIS RECALL (REMOVAL) Abiomed will replace all affected pumps that are still in your inventory using a phased replacement approach. The benefits of using the pump outweigh the risks of pump stop due to purge leaks. To mitigate leaks from sidearm damage and/or the yellow luer, it is critical to refer to the Important Information section below for best practices in the event you must use an affected Impella 5.5 with SmartAssist Set while you wait for a replacement pump. Please c |
| Quantity | 610 units |
| Distribution | US Nationwide. Japan, Saudi Arabia, Kuwait, Italy, Spain, Switzerland, Austria, France, Great Britain, Croatia, Serbia, Norway, Slovenia, Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.