Recall Z-2338-2024 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Maquet Cardiovascular, LLC
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System 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 cu
| 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 | 2463 units units US /330 units OUS |
| Distribution | NationwideForeign: AT DE DK ES GB HK IT NL ZA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101274 | VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM Maquet Cardiovascular, LLC, Jun 11, 2010 |