Z-3281-2018Class II

AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/...

Name: Z-3281-2018 AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/...
Creator: Stryker Neurovascular
Published: 2018-05-02
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2018-05-02 / Terminated / root cause: manufacturing process

FDA source

Stryker Neurovascular began a recall of 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... on 2018-05-02. FDA classified it as Class II and gives the reason as "The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3281-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-02
Posted: 2018-09-28
Recalling firm: Stryker Corp.
Product: 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.
Product code: DQY Catheter, Percutaneous
Reason for recall: The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 5/2/2018, "Urgent Medical Device Customer Communication" notifications were mailed via courier. Customers were informed to complete and return a Customer Acknowledgement Form. Customers with questions are encouraged to call (510) 413-2100.
Quantity in commerce: 15 units
Distribution: Only U.S. Consignees: CO,NJ,NY, OH,PA, and WV.
Product codes and lots: Lot No. 20156091 ;UPN: GEN-10800-80-S2 UDI (01)07613327298253 (17)201130 (10) 20156091.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3281-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3281-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-09-28

Product code DQY

K152876Class IILong Sheath or Ls, 70 Cm, Long Sheath or Ls, 80 Cm, Long Sheath or Ls, 90 CmTni Manufacturing, Inc. / cleared 2016-01-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)