Recall Z-1456-2017 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Maquet Cardiovascular, LLC
VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with the 7-mm Endoscope and is intended for specific use with the VASOVIEW HEMOPRO Power Supply.
| Date | Jan 27, 2017 |
| Status | Terminated |
| Reason | Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the device exhibiting the failure mode of intermittent or no power. |
| Root cause | Under Investigation by firm |
| Action | Maquet Inc. issued an Urgent Removal Correction Notice letter dated January 27, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check inventory for affected device. Remove and keep it in a secure location to preclude being used. Customers were asked to complete the Medical Device Removal Response Form and return to Maquet by e-mailing a scanned copy to HemoproPower@getinge.com or by faxing the form to 1-973-629-1518. |
| Quantity | 4283 units |
| Distribution | US Nationwide Distribution |
| 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 |