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

Recall Z-0805-2017 — OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

U.S. FDA — Device Enforcement · United States · 2016-10-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0805-2017
Date of alert
2016-10-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Oscor, Inc.
Product category
device
Product type
Devices
Reported risk: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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