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

Recall Z-0482-2015 — Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion.

U.S. FDA — Device Enforcement · United States · 2014-10-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0482-2015
Date of alert
2014-10-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Neurovascular
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
12693091
Reported risk: Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
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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