Recall Z-2741-2026 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Maquet Cardiovascular, LLC
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274.
| Date | Jul 15, 2026 (initiated Jun 2, 2026) |
| Status | Open, Classified |
| Reason | Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026. |
| Root cause | Under Investigation by firm |
| Action | Getinge issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 6/18/2026 via FedEx. The notice explained the issue, risk to health, and requested the following actions be taken: " Immediately identify and quarantine all affected Vasoview Hemopro 2 devices from lot 3000547797. " Do not use affected devices. " If an affected device was used, no further intervention is required. Standard post-operative wound care per facility protocol should be followed. " If any affected devices were transferred within your organization or to another organization, ensure this notice is shared wit |
| Quantity | 205 units |
| Distribution | US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR. |
| 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 |