FDAApril 18, 2019device
Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-11196-70, 70cm, b) REF: INC-11196-80, 80cm, c) REF: INC-11196-90, 90cm Product Usage: Indications for Use: The AXS Infinity LS Plus Long Sheath is indicated for ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft.
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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- FDADaig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
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