Stryker AXS Vecta 71 Aspiration Catheter Recall for Breakage Risk
Stryker Neurovascular is recalling AXS Vecta 71 Aspiration Catheters because they may break, fracture, or kink if improperly removed or during use.
What this means for you
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 breakage/kinking) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Stryker Neurovascular is recalling 1,405 units of AXS Vecta 71 Aspiration Catheters. The recall covers specific catalog numbers (INC-11129-115, INC-11129-125, and INC-11129-132) with a use-by date of November 29, 2021. These devices are indicated for the revascularization of patients with acute ischemic stroke.
The firm identified a potential problem where the catheters may break, fracture, or kink, bend if they are improperly removed from the packaging or dispenser hoop, or during catheter use. The agency has classified this as a Class II recall.
The affected products were distributed nationwide in the United States to various states, including Pennsylvania, Florida, California, Illinois, and others. No foreign distribution is reported. Consumers and healthcare providers should stop using the affected catheters and contact Stryker Neurovascular for further instructions.
The recalled product
- Product
- Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459210(17)211129(10)00000-00 Stryker Neurovascula
- Manufacturer
- Stryker Neurovascular
- Hazard
- Affected units
- 1,405
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 (20)
- Catalog # INC-11129-115: (Lot #'s 13170-01
- 13301-01
- 13494-01
- 13543-01
- 13545-01) Catalog # INC-11129-125: (Lot #'s 13163-01
- 13302-01
- 13500-01
- 13530-01) Catalog # INC-11129-132: (Lot #'s 13131-01
- 13156-01
- 13158-01
- 13176-01
- 13200-01
- 13201-01
- 13208-01
- 13212-01
- 13213-01
- 13215-01
- 13222-01
- 13238-01
- 13260-01
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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