Stryker AXS Infinity LS Plus Long Sheath Recalled for Brittle Behavior
Stryker Neurovascular is recalling AXS Infinity LS Plus Long Sheaths because a design issue can cause the device to become brittle and fracture.
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 and involves a risk-of-harm product (catheter fracture) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Stryker Neurovascular is recalling 2,435 units of the AXS Infinity LS Plus Long Sheath. The recall covers three reference numbers: INC-11196-70 (70cm), INC-11196-80 (80cm), and INC-11196-90 (90cm). The devices are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The recall is due to a design-related issue that can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft. The agency has classified this as a Class II recall.
The products were distributed nationwide across 41 states and the District of Columbia. The source text does not specify which healthcare facilities or patients are affected, nor does it report any specific injuries or illnesses. Healthcare providers should contact Stryker Neurovascular for further instructions on how to handle the recalled devices.
The recalled product
- Product
- Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-11196-70, 70cm, b) REF: INC-11196-80, 80cm, c) REF: INC-11196-90, 90cm Product Usage: Indications for Use: The AXS Infinity LS Plus…
- Manufacturer
- Stryker Neurovascular
- Affected units
- 2,435
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 (1)
- All lots
Distribution
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