Vessel harvesting systems recalled after out-of-box failures in harvesting tool jaws
Vasoview Hemopro 3 Endoscopic Vessel Harvesting Systems are recalled after out-of-box failures including deformed jaw attachments, jaws not fully closed and lifted heater wire. 98 units are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; device failures in a surgical harvesting tool are a potential harm and no injuries are reported.
Plain-English summary
The Vasoview Hemopro 3 Endoscopic Vessel Harvesting System, model C-VH-6000, UDI 00607567701274, is being recalled for lot and serial numbers 3000486429, 3000487231, 3000487726 and 3000488639. The system is a vessel harvesting kit designed for use with a 7 mm endoscope. The recall covers 98 units distributed in Florida, Illinois, Maryland and Texas.
The recall follows reports of out-of-box failures discovered during the limited launch phase. The failure modes included an 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 the box, and heater wire lifted or flexed away from the jaws. The FDA classified the action as Class II.
Hospitals holding these lots should quarantine them and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting kit designed for use with a 7 mm endoscope to cut and cauterize vessel branches.
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- out-of-box-failure
- instrument-defect
- vessel-harvesting
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Model No. C-VH-6000
- UDI: 00607567701274
- Lot/Serial No. 3000486429
- 3000487231
- 3000487726
- 3000488639.
Distribution
Distributed nationwide across the United States.
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