VasoView HemoPro 2 Endoscopic Vessel Harvesting System Class I Recall
FDA recalls VasoView HemoPro 2 endoscopic vessel harvesting systems due to risk of heater wire detachment and silicone peeling from the harvesting tool jaws, which could affect device function.
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. While potential heater wire detachment or silicone separation could compromise device function during critical surgical procedures, no deaths or serious injuries have been reported in the source.
Plain-English summary
Maquet Cardiovascular, LLC is recalling VasoView HemoPro 2 endoscopic vessel harvesting systems (Model VH-4000). The device is used in minimally invasive cardiovascular surgery to provide access for vessel harvesting. The recall affects 418,076 units worldwide, including 326,608 units distributed in the United States.
The recall is due to two potential issues: bent or detached heater wire, and silicone peeling or detaching from the jaws of the harvesting tool. These defects could compromise device performance during surgical procedures.
The affected systems were distributed nationwide in the United States and internationally to more than 40 countries, including Australia, Belgium, Canada, France, Germany, India, Japan, Mexico, Netherlands, Poland, South Korea, Spain, Switzerland, and Turkey.
Healthcare providers and facilities using VasoView HemoPro 2 systems should immediately discontinue use and contact Maquet Cardiovascular, LLC for instructions regarding affected units. The FDA classified this as a Class I recall, the most serious classification.
The recalled product
- Product
- VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- heater-wire-detachment
- 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-4000. UDI-DI: 00607567700406. All unexpired Lots.
Distribution
Distributed nationwide across the United States.
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