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U.S. Department of Health and Human Services

Class 1 Device Recall VasoView HemoPro Endoscopic Vessel Harvesting System

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 Class 1 Device Recall VasoView HemoPro Endoscopic Vessel Harvesting Systemsee related information
Date Initiated by FirmSeptember 20, 2024
Date PostedOctober 25, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0092-2025
Recall Event ID 95434
510(K)NumberK052274 K153194 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductVasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
Code Information UDI-DI: VH-3000-W - 00607567700413, VH-3500 - 00607567701250; Lot Numbers: VH-3000-W: 3000365379, 3000382334, 3000392749; VH-3500: 3000333967 3000354228 3000364520 3000376542 3000384902 3000400713 3000339701 3000355224 3000365391 3000376883 3000385174 3000401094 3000340534 3000355369 3000366446 3000377320 3000385849 3000401623 3000341133 3000355798 3000366831 3000377699 3000386206 3000402378 3000341675 3000356048 3000367160 3000378079 3000386871 3000403161 3000342250 3000357837 3000367439 3000378654 3000387986 3000403837 3000342251 3000360574 3000367542 3000379282 3000387987 3000404029 3000343264 3000360576 3000367852 3000379691 3000388401 3000404374 3000343266 3000360775 3000368165 3000380264 3000388676 3000404720 3000344887 3000361036 3000368658 3000380475 3000389329 3000411951 3000345068 3000361423 3000369005 3000380671 3000392530 3000346640 3000361707 3000369122 3000381049 3000392531 3000351187 3000362064 3000369645 3000381287 3000393159 3000351376 3000362258 3000370069 3000381620 3000393427 3000351407 3000362671 3000370290 3000382054 3000393838 3000351619 3000362933 3000372257 3000382868 3000394234 3000351747 3000363162 3000375534 3000383367 3000395128 3000351860 3000363947 3000375776 3000383779 3000398856 3000352770 3000364082 3000376132 3000384088 3000399341 3000354226 3000364309 3000376388 3000384382 3000399911
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information ContactKenisha Williams
973-709-7860
Manufacturer Reason
for Recall		There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.
FDA Determined
Cause 2		Device Design
ActionAn URGENT MEDICAL DEVICE- REMOVAL notification letter dated 9/20/24 was sent to customers. Actions to be taken by the customer: 1. Forward this information to all current and potential VasoView HemoPro Endoscopic Vessel Harvesting System users within your hospital/facility. 2. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. 3. Examine your inventory immediately to find and remove from use any of the VasoView HemoPro EVH Systems with the product codes and lot numbers listed in this notice. 4. Return any unused/unexpired affected product to MCV /Getinge. Contact MCV/Getinge Customer Service at 1-888-880-2874 between 6 am and 5 pm PST (Pacific Standard Time) to request a return authorization number (RMA) and shipping instructions. If you have an affected product, you are entitled to a credit. 5. Whether or not you have affected the product, please complete and sign the MEDICAL DEVICE REMOVAL - RESPONSE FORM (page 5) to acknowledge receipt of this notification. Return the completed form to MCV/Getinge by emailing a scanned copy to Hemopro-peeling-detachedsilicone2024.act@getinge.com or by faxing the form to + 1 (866) 594 8101. Actions to be taken by Getinge: MCV/Getinge is continuing to investigate this issue to determine and implement appropriate actions to prevent the recurrence of this failure. MCV /Getinge will notify customers if additional action is needed to address this issue. Getinge will facilitate the removal of affected products from your facility and provide credit for your return of these products. This removal only affects the products listed on page 1; no other products are affected by this medical device removal. If you have any questions, contact your MCV /Getinge representative or call the MCV/Getinge Customer Support at 1-888-880-2874, Monday through Friday, between 6 am and 5 pm PST.
Quantity in Commerce28,809 units
DistributionWorldwide distribution. US Nationwide. Brazil, China, and Hong Kong.
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
510(K)s with Product Code = GEI
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