Recall Z-0712-2025

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: Device Design

Action taken

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.