Vasoview Hemopro 3 surgical system recalled for out-of-box mechanical failures
Maquet Cardiovascular is recalling the Vasoview Hemopro 3 endoscopic vessel harvesting system due to out-of-box mechanical failures including deformed jaws and heater wire defects discovered during the limited launch phase.
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: This is a risk-of-harm medical device where mechanical failures have been confirmed but no injuries or illnesses have been reported. The device malfunctions (deformed jaws, heating element defects, jaw closure failures) would impair the surgical system's ability to function safely and effectively during vessel harvesting procedures.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Vasoview Hemopro 3 Endoscopic Vessel Harvesting (EVH) System, which includes Model No. C-VH-6000, VH-6001, and VH-6010. This surgical instrument kit is designed to be used with a 7 mm endoscope to cut and cauterize blood vessel branches. The system's harvesting tool features curved, insulated jaws with heating elements that operate through heat and pressure.
The recall was initiated due to reports of out-of-box failures discovered during the limited launch phase. The reported failure modes include angled deformity at the attachment site of the harvesting tool jaws and the distal end of the harvesting tool shaft, jaws that fail to close completely when removed from the box, and heater wire that becomes lifted or flexed away from the jaws.
A total of 98 units were distributed nationwide to facilities in Florida, Illinois, Maryland, and Texas. The affected lot/serial numbers are 3000486429, 3000487231, 3000487726, and 3000488639. Healthcare facilities and clinicians who have received affected units should contact Maquet Cardiovascular immediately to determine whether replacement units or other remedies are available. Do not use units from the affected lots until replacement or remedy options have been confirmed.
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
- jaw-closure-failure
- heating-element-malfunction
- structural-defect
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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