Stryker AXS Vecta 74 Aspiration Catheter Recall for Potential Fracture
Stryker Neurovascular is recalling 1,405 AXS Vecta 74 Aspiration Catheters because they may break, fracture, or kink if improperly removed or during use.
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 the hazard involves a risk of harm (catheter fracture/kinking) in a medical device where specific injury reports are not detailed in the source text, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Stryker Neurovascular is recalling 1,405 units of the AXS Vecta 74 Aspiration Catheter. The affected devices are identified by catalog numbers INC-11597-115, INC-11597-125, and INC-11597-132, with a use-by date of November 29, 2021. The devices are sterile, ethylene oxide sterilized, and prescription-only.
The recall was initiated because the firm became aware of a potential problem where the catheters may break, fracture, or kink, bend if improperly removed from the packaging or dispenser hoop, or during catheter use. The AXS Vecta Aspiration System is indicated for the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within 8 hours of symptom onset.
The affected devices were distributed nationwide in the United States to 38 states and the District of Columbia. No foreign countries or US government entities were included in the distribution. Healthcare providers and facilities should stop using the affected devices and contact Stryker Neurovascular for further instructions.
The recalled product
- Product
- Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459241(17)211129(10)00000-00 Stryker…
- Manufacturer
- Stryker Neurovascular
- Hazard
- Affected units
- 1,405
Distribution
Part of a larger recall action
This product is one of 2 recalled by Stryker Neurovascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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