The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System… recallZ-2741-2026 · Maquet Cardiovascular, LLC · initiated Jun 2, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Cardiovascular, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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].
Recall details
- Recall number
- Z-2741-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 2, 2026
- Posted by the FDA
- Jul 15, 2026
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- 205 units
- Product code
- GEI
- FDA submissions
- K101274
- Distribution
- US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
Product description
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.
Code information (models, lots, serial numbers)
UDI 00607567700406, Serial/Lot Number 3000547797
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vasoview Hemopro 2 VH-4000Maquet Cardiovascular LLC · Electrosurgical, Cutting & Coagulation & Accessories6 recalls1 death3,232 reports
Other devices under the same FDA submission
2 devices cleared under K101274 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Hemopro 2 w/Vasoshield VH-4001Maquet Cardiovascular LLC · Electrosurgical, Cutting & Coagulation & Accessories4 recalls105 reports
- HemoPro 2 Adaptor C-VH-4020Maquet Cardiovascular LLC · Electrosurgical, Cutting & Coagulation & Accessories79 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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