Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Har
FDA device recall Z-2636-2025 · posted 2025-09-25 · Open, Classified
Recall details
- Recalling firm
- Maquet Cardiovascular, LLC
- Reason for recall
- Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws.
- Action taken
- Getinge Field Representatives contacted impacted accounts by telephone on 8/6/25 to notify them of this recall action and provide instructions for quarantine and return of affected devices. Consignees were asked to stop all visual inspection and return all HemoPro 3 units. Returns can be coordinated by calling or emailing Michele Kanis for an RMA at michele.kanis@getinge.com or (408)635-0647. Consignees are to utilize HemoPro 2 in place of HemoPro 3 units. Getinge Field Representatives delivered an updated URGENT MEDICAL DEVICE RECALL notice starting on 10/6/25 dated October 2025. The written notification is a supplement to the verbal notification made previously.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- GEI
- Quantity affected
- 98 units
- Distribution
- US Nationwide distribution in the states of FL, IL, MD & TX.
- Date initiated
- 2025-08-06
- Date posted
- 2025-09-25
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010) (K251238) | Maquet Cardiovascular, LLC | 2025-05-30 |