Recall Z-0092-2025 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Maquet Cardiovascular, LLC
VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
| Date | Oct 25, 2024 (initiated Sep 20, 2024) |
| Status | Open, Classified |
| Reason | There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use. |
| Root cause | Device Design |
| Action | An URGENT MEDICAL DEVICE- REMOVAL notification letter dated 9/20/24 was sent to customers. Actions to be taken by the customer: 1. Forward this information to all current and potential VasoView HemoPro Endoscopic Vessel Harvesting System users within your hospital/facility. 2. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. 3. Examine your inventory immediately to find and remove from use any of the VasoView HemoPro EVH Systems with the product codes and lot numbers listed in this notice. 4. |
| Quantity | 28,809 units |
| Distribution | Worldwide distribution. US Nationwide. Brazil, China, and Hong Kong. |
| FDA record | Open on fda.gov |