FDA Recalls VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System for Sterilization Failure
Maquet Cardiovascular is recalling VASOVIEW HEMOPRO endoscopic vessel harvesting systems because some batches were not sterilized to the required specifications.
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 an FDA Class II medical device recall. While inadequate sterilization presents a risk of harm, no illnesses or injuries have been reported, fitting the High severity category for risk-of-harm products without reported injury.
Plain-English summary
The FDA is recalling VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System (Model C-VH-3000-W), manufactured by Maquet Cardiovascular, LLC. A total of 235 units are affected by this recall.
The recall was issued because some batches of the product were not sterilized to their minimum sterilization specification. The affected lot number is 3000274687.
The recalled systems were distributed worldwide, including the United States, Brazil, and China.
The recalled product
- Product
- VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- sterilization-failure
- infection-risk
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 (2)
- UDI-DI: 00607567700345
- Lot Numbers: 3000274687
Distribution
Distributed nationwide across the United States.
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