Reported Jul 3, 2024 · Ongoing
The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended…
Maquet Cardiovascular, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular, LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- The VASOVIEW HemoPro 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.
- Lot codes and dates
Model No. VH-3500VH-3000-W
- UDI
114 of 114 codes
0060756770125000607567700345Lot No. 3000314373300031482130003160233000316024300031602730003175013000317575300031757630003183023000318901300032014030003201413000320773300032148330003217233000323214300032439730003244093000325013300032524930003256893000325776300032820630003285613000328562300032972330003304453000331131300033138830003324283000332510300033299330003335243000333829300033395630003339673000334315300033567030003367083000337272300033970130003405343000341133300034167530003422503000342251300034326430003432663000344887300035118730003527703000354226300035422830003552243000355369300035579830003560483000357837
- Amount recalled
- 37,186 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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