Recall Z-1577-2025 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Maquet Cardiovascular, LLC
Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
| Date | Apr 16, 2025 (initiated Mar 10, 2025) |
| Status | Open, Classified |
| Reason | Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE REMOVAL notification dated March 2025 was mailed to consignees. The notification instructs consignees to examine their inventory for impacted serial numbers. For power supplies whose serial numbers are not listed in the provided Appendix A of recalled devices, devices can continue to be used. If power supplies with affected serial numbers are identified as being in stock, the associated devices should not be used and returned to Getinge. Returns are facilitated by contacting Getinge Customer Service at 888-800-2874 between the hours of 6:00 AM and 5:00 PM PST to reques |
| Quantity | 110 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, CA, CO, DC, FL, GA, IA, ID, IL, IN, KY, MD, MI, MN, MO, NC, NH, NJ, NY, OH, PA, PR, TX, UT, VA, WI, WV and the countries of China, Japan, Netherlands, New Zealand, Singapore, United Kingdom, United States. |
| 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 |