Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1898-2021 — VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F 10/40/1200mm OUS; VENEL10060 /Venovo 8F 10/60/1200mm OUS; VENEL10080 /Venovo 8F 10/80/1200mm OUS; VENEL10100 /Venovo 8F 10/100/1200mm OUS; VENEL10120 /Venovo 8F 10/120/1200mm OUS; VENEL10140 /Venovo 8F 1

U.S. FDA — Device Enforcement · United States · 2020-12-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1898-2021
Date of alert
2020-12-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Bard Peripheral Vascular Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00801741102004
Reported risk: Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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