VasoView HemoPro Vessel Harvesting System Recalled for Silicone Component Detachment
Maquet Cardiovascular is recalling the VasoView HemoPro Endoscopic Vessel Harvesting System due to silicone detachment from the Harvesting Tool Jaws during use. This FDA Class I recall affects 28,809 units worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which mandates a minimum severity score of 4 per the rubric. Although no illnesses, injuries, or deaths have been reported in the source text, the Class I classification reflects the serious risk posed by a critical component failure (silicone detachment) occurring during active surgical use.
Plain-English summary
The VasoView HemoPro Endoscopic Vessel Harvesting System (Product Codes VH-3000-W and VH-3500), manufactured by Maquet Cardiovascular, LLC, is being recalled by the FDA. The device is used for vessel harvesting during cardiac surgery.
The recall was issued because silicone has been reported to detach from the Jaws of the Harvesting Tool during use. This component failure during active surgery could compromise the integrity of the harvested vessel and affect surgical outcomes.
A total of 28,809 units have been distributed worldwide, including in the United States, Brazil, China, and Hong Kong. Specific affected lot numbers have been identified by the manufacturer.
Healthcare facilities should immediately discontinue use of affected units and verify device lot numbers against the recall notice. Patients who have undergone surgery with this device should consult their healthcare provider if they have concerns.
The recalled product
- Product
- VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
- Manufacturer
- Maquet Cardiovascular, LLC
- Affected units
- 28,809
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 (5)
- UDI-DI: VH-3000-W - 00607567700413
- VH-3500 - 00607567701250
- Lot Numbers: VH-3000-W: 3000365379
- 3000382334
- 3000392749
Distribution
Distributed nationwide across the United States.
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