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.
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 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…
- 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Stryker Neurovascular
See all →- HighStryker Neurovascular INZONE Detachment System battery drain
FDA (Devices) · 2026-07-01
- HighTrevo Trak 21 Microcatheter Distributed with Incorrect Instructions and Labels
FDA (Devices) · 2024-10-16
- HighSynchro SELECT Guidewires may have PTFE coating damage
FDA (Devices) · 2024-06-12
- HighSynchro2 Guidewires: PTFE coating damage from improper backloading technique
FDA (Devices) · 2024-06-12
- HighStryker Synchro Neuro Guidewires Recalled for PTFE Coating Damage Risk
FDA (Devices) · 2024-06-12
Same hazard · device breakage
See all →- HighTissium Peripheral Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighPeripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighTissium COAPTIUM CONNECT Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighSurgify Halo Surgical Burr Breakage Risk During Spinal Surgery
FDA (Devices) · 2026-07-01
- SevereSurgify Halo 4.0mm Extendable Surgical Burr Recall for Breakage Risk
FDA (Devices) · 2026-07-01
Similar recalls
- HighStryker AXS Infinity LS Plus Long Sheath Recalled for Brittle Behavior
FDA (Devices) · 2019-06-12
- HighStryker Wingspan Stent System Recalled for Coating Damage
FDA (Devices) · 2018-09-19
- ModerateStryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates
FDA (Devices) · 2013-12-25
- ModerateStryker Orthobiologics Aliquot Reamer Recalled for Catheter Breakage Risk
FDA (Devices) · 2013-06-05
- ModerateStryker Neurovascular Microcatheters Recalled for Shelf-Labeling Errors
FDA (Devices) · 2013-12-25
- ModerateStryker Orthobiologics Aliquot Beveled Needle Recalled for Catheter Breakage
FDA (Devices) · 2013-06-05