FDAClass IIJuly 17, 2024

The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting recall

The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting…

Why was The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting recalled?

There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 00607567700345 Lot Numbers; 3000371260 3000378288 3000362934 3000371798 3000378554 3000372477 3000378950 3000376542 3000380314 3000377320 3000380847

Product
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting…
Recalling firm
Maquet Cardiovascular, LLC
Quantity
600 units
Distribution
NationwideForeign: AT DE DK ES GB HK IT NL ZA
Recall date
July 17, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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