Recall Z-0711-2025 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Maquet Cardiovascular, LLC
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
| Date | Jan 3, 2025 (initiated Dec 9, 2024) |
| Status | Open, Classified |
| Reason | Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool |
| Root cause | Device Design |
| Action | Getinge notified consignees on 12/09/2024 via Urgent Medical Device Correction letter posted digitally on Getinge.com and sent to consignees via letter. Consignees were not instructed to return affected units, but instead to review the IFU information provided with the letter to minimize over-delivery of energy and mitigate risks. Getinge instructed consignees to notify customers if further distributed, as well as requested to complete and return the MEDICAL DEVICE CORRECTION RESPONSE FORM. Training to reinforce precautions and appropriate use of the device is expected to be deployed and co |
| Quantity | 418,076 units (326,608 US, 91,468 OUS) |
| Distribution | Nationwide distribution. International distribution to Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Hong Kong, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Malaysia, Mexico, Netherlands, Netherlands, New |
| 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 |