FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular, LLC: 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.
- Recall number
- Z-2741-2026
- 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.
- Status
- Open, Classified
- Initiated
- 2026-06-02
- Posted
- 2026-07-15
- Terminated
- not on file
- Reason
- 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
- 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 recallresponses.qrc@getinge.com.
- Quantity
- 205 units
- Distribution
- US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
- Lot, serial or model codes
- UDI 00607567700406, Serial/Lot Number 3000547797
- 510(k) numbers
- ["K101274"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 2242352
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28