Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU... — FDA record Z-0210-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 19, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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).
Reason
Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
Classification
Class II
Recalling firm
Maquet Cardiovascular, LLC
Quantity
N/A
Agency-reported status
Ongoing
Source record identifier
Z-0210-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityUDI-DI: 00607567700239, Lot: 3000313857.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Nov 8, 2023
Recall initiation date
Sep 19, 2023
Center classification date
Nov 2, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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