Maquet Cardiovascular, LLC recalls VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indica…

Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool

Getinge 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 notify customers if further distributed, as well as requested to complete and return the MEDICAL DEVICE CORRECTION RESPONSE FORM. 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: On 01/31/2025 an updated URGENT MEDICAL DEVICE CORRECTION letter was sent to customers. Consignees were instructed to review the IFU information provided in Appendix A of the letter and consider the listed areas to mitigate the risks. Getinge has created a training video, accessible via a QR code or link, to guide users on the proper use of the device and reinforce essential precautions. Consignees were instructed to notify customers if product was further distributed. Additionally, consignees were instructed to complete, sign and return the provided MEDICAL DEVICE CORRECTION RESPONSE FORM. UPDATE: On 07/11/2025 an updated Urgent Medical Device Correction Update letter was posted on Getinge.com and sent to consignees via letter. The updated communication informs users that the Instructions for Use (IFU) for the Vasoview Hemopro 2 EVH System has been revised to address the bent or detached heater wire and silicone peeling or detaching from the Jaws of the Harvesting Tool. Consignees were instructed to review the updated IFU, view the training video linked in the letter, complete and return the MEDICAL DEVICE CORRECTION RESPONSE FORM, and notify customers if product was further distributed.

• FDA enforcement recordOfficial FDA database entry for Z-0711-2025
• FDA 510(k) clearance · K101274The device's official FDA premarket clearance record
• FDA device classification · GEIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4400The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Maquet Cardiovascular, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.