FDAMay 2, 2018device
AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing,...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
What to do
FDA enforcement status: Terminated
Brands named
stryker neurovascularstryker
UPCs
07613327298253
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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