Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System… recallZ-0210-2024 · Maquet Cardiovascular, LLC · initiated Sep 19, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Cardiovascular, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
FDA root cause category: Under Investigation by firm
What the company is doing
An Urgent Medical Device Removal notice was sent October 06, 2023 advising customers examine inventory, stop using, and remove any affected product from areas of use and return it to Getinge through Customer Service (888) 880-2874 between 6:00AM - 5:00PM PST. The notification should be forwarded to any system users and to any customers to which product was further distributed to. Complete and return the acknowledgement form to [email protected] or fax to (866) 326-9165.
Recall details
- Recall number
- Z-0210-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 19, 2023
- Posted by the FDA
- Nov 2, 2023
- Recalling firm
- Maquet Cardiovascular, LLC
- Product code
- GEI
- FDA submissions
- K091733
- Distribution
- US (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.
Product description
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).
Code information (models, lots, serial numbers)
UDI-DI: 00607567700239, Lot: 3000313857.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vasoview VV6 Pro VH-2400Maquet Cardiovascular LLC · Electrosurgical, Cutting & Coagulation & Accessories1 recall74 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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