AXS INFINITY LS recallZ-3281-2018 · Stryker Neurovascular · initiated May 2, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Neurovascular or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-3281-2018
- Status
- Terminated
- Initiated by the company
- May 2, 2018
- Recalling firm
- Stryker Neurovascular
- Quantity
- 15 units
- Product code
- DQY
- FDA submissions
- K152876
- Distribution
- Only U.S. Consignees: CO,NJ,NY, OH,PA, and WV.
Product description
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.
Code information (models, lots, serial numbers)
Lot No. 20156091 ;UPN: GEN-10800-80-S2 UDI (01)07613327298253 (17)201130 (10) 20156091.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AXS INFINITY LS GEN-10800-80Stryker Corporation · CATHETER, PERCUTANEOUS1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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