Endoscopic Vessel Harvesting System Recalled for Incorrect Outer Box Packaging
Vasoview 6 Pro endoscopic vessel harvesting systems were packaged in incorrect outer boxes displaying artwork for a different device (Vasoview Hemopro 2). The inner labels and product documentation are correct.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II device recall involving incorrect outer packaging and labeling with no reported illnesses or injuries. The hazard is a packaging-only and minor labeling problem without described risk of harm, meeting the criterion for Moderate severity.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Vasoview 6 Pro (VV6) endoscopic vessel harvesting systems due to incorrect outer box packaging. Lot 3000313857 (UDI-DI 00607567700239) was shipped with outer boxes displaying artwork and illustrations for the Vasoview Hemopro 2 (HP2) device instead of the correct VV6 packaging.
The product name, model number (VH-2400), and instructions for use are correctly printed on the inner label and instruction documentation. The issue is limited to the outer packaging presentation.
The affected devices were distributed to healthcare facilities in the following U.S. states: Alabama, Arkansas, California, Florida, Georgia, Indiana, Kentucky, Michigan, New Jersey, Oklahoma, Pennsylvania, Tennessee, and Texas, as well as Canada.
The recalled product
- Product
- Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview Hemopro 2 (HP2).
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- packaging-error
- mislabeling
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: 00607567700239
- Lot: 3000313857.
Distribution
Distributed in 13 states:
- AL
- AR
- CA
- FL
- GA
- IN
- KY
- MI
- NJ
- OK
- PA
- TN
- TX
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