FDAFDA · Food and drugs·Recall number Z-2175-2024
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, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.
Published July 3, 2024 · Recall initiated: May 17, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Maquet Cardiovascular, LLC
- Distributor
- Worldwide distribution - US Nationwide and the countries of Australia Brazil, Canada, China, EEA, India, Korea, New Zealand, Southern Africa, Taiwan, Thailand, Turkey, & United Kingdom.
- Lot
- 1. Model Number: VH-4000. UDI-DI: 00607567700406. All lot numbers within expiration. 2. Model Number: VH-4001. UDI-DI: 00607567700451. All lot numbers within expiration.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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