Vasoview Hemopro 2 Vessel Harvesting System Recalled for Heater Wire and Silicone Defects
Maquet Cardiovascular is recalling the Vasoview Hemopro 2 Vessel Harvesting System due to potential heater wire and silicone defects. These could affect device function during minimally invasive surgery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall per agency classification. The heater wire and silicone defects could affect device function in surgical settings. No reported illnesses or injuries.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System, Model VH-4001. This device is used in minimally invasive surgery for vessel harvesting. Approximately 11,101 units have been distributed nationwide and to over 40 countries.
The recalled devices may have two defects: a bent or detached heater wire, and silicone that may peel or detach from the jaws of the harvesting tool. These defects could affect the device's function during surgery.
Healthcare facilities and surgeons using this device should contact Maquet Cardiovascular for instructions on device returns and replacement options. The recall affects all unexpired lots of Model VH-4001.
Patients who have undergone procedures using this device should consult their healthcare provider if they have concerns about their surgery or recovery.
The recalled product
- Product
- Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- heater-wire-defect
- silicone-peeling
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 (1)
- Model Number: VH-4001. UDI-DI: 00607567700451. All unexpired Lots.
Distribution
Distributed nationwide across the United States.
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