Z-2741-2026Class II

The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile...

Name: Z-2741-2026 The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile...
Creator: Maquet Cardiovascular, LLC
Published: 2026-06-02
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2026-06-02 / Open, Classified / root cause: sterility

FDA source

Maquet Cardiovascular, LLC began a recall of The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for... on 2026-06-02. FDA classified it as Class II and gives the reason as "Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2741-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-02
Posted: 2026-07-15
Recalling firm: Maquet Cardiovascular LLC
Product: The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: Getinge issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 6/18/2026 via FedEx. The notice explained the issue, risk to health, and requested the following actions be taken: " Immediately identify and quarantine all affected Vasoview Hemopro 2 devices from lot 3000547797. " Do not use affected devices. " If an affected device was used, no further intervention is required. Standard post-operative wound care per facility protocol should be followed. " If any affected devices were transferred within your organization or to another organization, ensure this notice is shared with the appropriate individuals. " Contact Getinge Customer Service 1-888-880-2874 or your Getinge representative to coordinate return of the affected units and replacement product. " Complete and return the enclosed response form to Getinge by e-mailing a copy to [email protected].
Quantity in commerce: 205 units
Distribution: US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
Product codes and lots: UDI 00607567700406, Serial/Lot Number 3000547797

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2741-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2741-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-15

Product code GEI

K101274Class IIVasoview Hemopro 2 Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC / cleared 2010-06-11

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)