Recall Z-2337-2024 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Maquet Cardiovascular, LLC
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch c
| Date | Jul 11, 2024 (initiated May 31, 2024) |
| Status | Open, Classified |
| Reason | There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue. |
| Root cause | Under Investigation by firm |
| Action | Maquet Cardiovascular, LLC (MCV), a subsidiary of Getinge issued Urgent Medical Device Removal Letter to consignees via FedEx 2-Day Delivery with Signature Proof of Delivery (SPOD) on 31 May 2024. Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any of the HemoPro devices with the product code/lot number(s) listed in this notice. " Prior to use, always refer to Instructions for Use, Section Warning and Precautions , specifically: o HemoPro 2 Always advance the C-Ring and Harvesting Tool under endoscopic visu |
| Quantity | 600 units |
| Distribution | NationwideForeign: AT DE DK ES GB HK IT NL ZA |
| 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 |