Stryker AXS Infinity LS Long Sheath Recalled for Specification Exceedance
Stryker Neurovascular is recalling 15 units of the AXS Infinity LS Long Sheath because the dilator's outer diameter exceeded specifications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a High severity score (3) in the absence of reported injuries or hospitalizations, as the defect is a specification exceedance rather than a confirmed safety failure.
Plain-English summary
Stryker Neurovascular is recalling 15 units of the AXS Infinity LS Long Sheath. The recall involves specific 6F/0.088in sheaths with lengths of 70cm, 80cm, and 90cm, manufactured in Ireland and sterilized with Ethylene Oxide. The product is identified by Lot No. 20156091 and UDI (01)07613327298253.
The recall was initiated because the outer diameter (OD) specification of the AXS Infinity LS Long Sheath Dilator was exceeded. This is a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
The affected units were distributed only to U.S. consignees in Colorado, New Jersey, New York, Ohio, Pennsylvania, and West Virginia. Healthcare providers and facilities should check their inventory for this specific lot number and stop using the product if found.
The recalled product
- 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…
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
- Hazard
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot No. 20156091
- UPN: GEN-10800-80-S2 UDI (01)07613327298253 (17)201130 (10) 20156091.
Distribution
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