FDANovember 3, 2017device
Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M0033PK62523002 Stroke intervention kit
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
stryker neurovascularstryker
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDABARD Dynamic Tip Steerable, Product Number 6DYNTP001;2026-04-10
- FDABARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDADaig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
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