Z-0210-2024Class II

Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label...

Name: Z-0210-2024 Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label...
Creator: Maquet Cardiovascular, LLC
Published: 2023-09-19
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2023-09-19 / Open, Classified / root cause: packaging

FDA source

Maquet Cardiovascular, LLC began a recall of 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... on 2023-09-19. FDA classified it as Class II and gives the reason as "Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0210-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-19
Posted: 2023-11-02
Recalling firm: Maquet Cardiovascular LLC
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).
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
Root cause tag: packaging
FDA root cause: Under Investigation by 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.
Distribution: US (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.
Product codes and lots: UDI-DI: 00607567700239, Lot: 3000313857.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0210-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0210-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-08	2023-11-02

Product code GEI

K091733Class IIVasoview 6 Pro Endoscopic Vessel Harvesting System, Model Vh-2500Maquet Cardiovascular, LLC / cleared 2009-08-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)