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).
FDA Recall Z-0210-2024 · Posted 2023-11-02
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Recalling FirmMaquet Cardiovascular, LLC
Recall StatusOpen, Classified
Product CodeGEI
Date Initiated2023-09-19
Reason for Recall
Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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