Recall Z-1074-2024 ยท OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Abiomed, Inc.
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6) Product Code 1000323 - RP Flex with SmartAssist (7) Product Codes 0550-0008 and 100010
| Date | Feb 12, 2024 (initiated Dec 27, 2023) |
| Status | Open, Classified |
| Reason | New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device. |
| Root cause | Labeling Change Control |
| Action | On December 27, 2023, the firm notified affected customers via URGENT MEDICAL DEVICE CORRECTION letters. Customers were informed of the IFU update, which included a New Warning: "To reduce the possibility of fibers being drawn into the Impella, customers should avoid exposing the inlet and cannula section of the Impella Heart Pumps to any surfaces or fluid baths where the device can come into contact with loose or floating fibers." The IFU udpate also includes updates to Potential Adverse Events and Warnings to add potential of cardiac or vascular injury. That part of the recall is classifi |
| Quantity | 92515 |
| Distribution | Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.