Recall Z-2175-2024 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Maquet Cardiovascular, LLC
The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope,
| Date | Jun 24, 2024 (initiated May 17, 2024) |
| Status | Open, Classified |
| Reason | Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended. |
| Root cause | Device Design |
| Action | Consignees were mailed an URGENT MEDICAL DEVICE - CORRECTION notice, dated 5/17/24. In the notice consignees are instructed to make users aware of the additional safety information provided in the notification by forwarding the notice to users in their facility and locations where devices are stored. Additionally, consignees are asked to return the provided response form by email to VVHemoPro2024.act@getinge.com or by fax to 800-892-0487. Getinge will be updating the Instructions for Use (IFU) of devices to include the additional safety information related to fluid ingress. Questions can be di |
| Quantity | 430,037 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia Brazil, Canada, China, EEA, India, Korea, New Zealand, Southern Africa, Taiwan, Thailand, Turkey, & United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101274 | VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM Maquet Cardiovascular, LLC, Jun 11, 2010 |