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

Recall Z-1284-2024 — CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use

U.S. FDA — Device Enforcement · Switzerland · 2024-02-02 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1284-2024
Date of alert
2024-02-02
Country / jurisdiction
Switzerland
Risk level
Class I
Risk type
recall
Brand
Medos International Sarl
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10886704082316
Reported risk: Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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