Recall Z-0724-2024 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Maquet Cardiovascular, LLC
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
| Date | Jan 12, 2024 (initiated Dec 1, 2023) |
| Status | Open, Classified |
| Reason | Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graft surgery. |
| Root cause | Component design/selection |
| Action | An Urgent Medical Device Correction notice dated December 1, 2023 was sent via FedEx 2-Day delivery. Please examine your inventory immediately to determine if you have any of the product codes and lot numbers listed in the notice and remove these from use. Return any unused/unexpired affected product to Maquet/Getinge. Please forward this information to all current and potential VasoView HemoPro EVH System users within your hospital / facility. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. If |
| Quantity | 38,094 units (US) |
| Distribution | US: OUS: China, Brazil, Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153194 | VASOVIEW HemoPro Endoscopic Vessel Harvesting System Maquet Cardiovascular, LLC, Apr 19, 2016 |