Exact FDA event identifier

Event 80652

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket: May 02, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Stryker Neurovascular

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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, One Long Dilator.

Z-3281-2018

Recall number: Z-3281-2018
Initiated: May 02, 2018
Classification: Class II
Status: Terminated
Recalling firm: Stryker Neurovascular
Quantity: 15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.

Code information

Lot No. 20156091 ;UPN: GEN-10800-80-S2 UDI (01)07613327298253 (17)201130 (10) 20156091.

Distribution pattern

Only U.S. Consignees: CO,NJ,NY, OH,PA, and WV.