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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 FirmDecember 09, 2024
Date PostedJanuary 03, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0711-2025
Recall Event ID 95908
510(K)NumberK101274 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductVasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Code Information Model Number: VH-4000. UDI-DI: 00607567700406. All unexpired Lots.
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
Manufacturer Reason
for Recall		Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
FDA Determined
Cause 2		Device Design
ActionGetinge notified consignees on 12/09/2024 via Urgent Medical Device Correction letter posted digitally on Getinge.com and sent to consignees via letter. Consignees were not instructed to return affected units, but instead to review the IFU information provided with the letter to minimize over-delivery of energy and mitigate risks. Getinge instructed consignees to forward the information to any affected personnel and users of the affected system or customers if the product was further distributed, as well as requested to complete and return the MEDICAL DEVICE CORRECTION RESPONSE FORM. Getinge is continuing to investigate the issues to determine and implement appropriate actions. Training to reinforce precautions and appropriate use of the device is expected to be deployed and communicated to all customers by end of January 2025. Update 2/3/2025*** On 01/31/2025 an updated URGENT MEDICAL DEVICE CORRECTION letter was sent to customers. Actions to be taken by the customer: 1. Review the IFU information provided in Appendix A, specifically note the following warnings to minimize over-delivery of energy: " When inserting or retracting the Harvesting Tool through the Harvesting Cannula, close the Jaws and ensure the Jaw tips are oriented upwards (concave side up) to prevent damage to the Jaws. " Application of energy without tissue between the Jaws of the Harvesting Tool should be kept to minimum in order to maximize Harvesting Tool performance. " When separation of the branch tissue is noticed, open the Jaws and stop application of energy by pushing the Activation Toggle into the forward most position and retract the Harvesting Tool slightly. NOTE: Once material has been transected, stop application of energy. 2. Consider the following to mitigate the risks: " Inspect the device prior to use for any signs of damage including silicone peeling away from the jaws. " Check the outer surface of the device for rough surfaces, sharp edges, or unusual protrusions that
Quantity in Commerce312,041 units (260823 US, 51218 OUS)
DistributionNationwide distribution. International distribution to Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Hong Kong, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Malaysia, Mexico, Netherlands, Netherlands, New Zealand, Oman, Panama, Peurto Rico, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates.
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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