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

Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm; UPN M0033PK42022002 Stroke intervention kit — recall Z-0276-2018

U.S. FDA — Device Enforcement · United States · 2017-11-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0276-2018
Date of alert
2017-11-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Neurovascular
Product category
device
Product type
Devices
Reported risk: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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