Recall Z-0980-2024 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 (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 1000080 and 0048-0045 - Impella CP with Smar
| Date | Feb 9, 2024 (initiated Dec 27, 2023) |
| Status | Open, Classified |
| Reason | IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling. |
| Root cause | Labeling Change Control |
| Action | Firm notified affected consignees of the updated warnings in the IFU beginning on December 27, 2023. Customers were provided with details of the IFU modifications. Customers should notify everyone at their facility who needs to be informed of this correction. If products have been forwarded to another facility, please notify that facility of the updated IFUs. Post a copy of the recall notice in a visible area for awareness. If you have questions or concerns regarding this notice, please contact recallcoordinators@abiomed.com and/or your local clinical field staff. |
| Quantity | 91,914 (65,857 US; 26,075 OUS) |
| 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.