Maquet Cardiovascular, LLC: The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: NationwideForeign: AT DE DK ES GB HK IT NL ZA Quantity: 600 units Lot/code info: UDI-DI: 00607567700345 Lot Numbers; 3000371260 3000378288 3000362934 3000371798 3000378554 3000372477 3000378950 3000376542 3000380314 3000377320 3000380847

UPC codes

00607567700345

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.