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

FDA device recall Z-2741-2026 · posted 2026-07-15 · Open, Classified

Recall details

Recalling firm

Maquet Cardiovascular, LLC

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.

Action taken

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 recallresponses.qrc@getinge.com.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GEI

Quantity affected

205 units

Distribution

US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.

Date initiated

2026-06-02

Date posted

2026-07-15

Location

Wayne, NJ

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