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U.S. Department of Health and Human Services

Class 2 Device Recall VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System

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 Class 2 Device Recall VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting Systemsee related information
Date Initiated by FirmJune 02, 2026
Date PostedJuly 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2741-2026
Recall Event ID 99259
510(K)NumberK101274 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductThe 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 UDI 00607567700406, Serial/Lot Number 3000547797
FEI Number 2242352
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionGetinge 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 in Commerce205 units
DistributionUS Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GEI
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