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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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
- Affected units
- 235
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.
Part of a larger recall action
This product is one of 3 recalled by Maquet Cardiovascular, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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