Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates
Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with use-by dates exceeding available shelf-life data.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates a labeling/shelf-life discrepancy without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Neurovascular is recalling specific medical devices, including the Stryker brand COMPLIANT 4MM X 20MM microcatheter, Excelsior SL-10/Excelsior 1018 Microcatheter, GDC 10, 18 Coils, GDC 18-Fibered VortX Shape Coil, GDC 18-Fibered VoliX Shape Coil, and TransForm Occlusion Balloon Catheters. These products are intended for use in the neurovasculature and peripheral vasculature for diagnostic and therapeutic procedures.
The recall was initiated because the products were shipped with "use by" dates that exceed currently available shelf-life data. According to the source text, all affected products remain within the earliest expiration date of April 2015.
The products were distributed nationwide in the United States and internationally to numerous countries, including Austria, Belgium, Canada, Germany, and Japan. Healthcare providers and facilities should verify the use-by dates on their inventory against the available shelf-life data and contact Stryker Neurovascular for further instructions.
The recalled product
- Product
- Stryker brand COMPLIANT 4MM X 20MM, Catalog Number: M003SRC04200; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are…
- Manufacturer
- Stryker Neurovascular
- Hazard
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)
- 17010968
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 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 19 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
- HighStryker Synchro Neuro Guidewires Recalled for PTFE Coating Damage Risk
FDA (Devices) · 2024-06-12
- 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
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateStryker GDC 360 Coils Recalled for Expiration Date Violations
FDA (Devices) · 2014-12-10
- ModerateStryker Neuroform 3 Stent System Recalled for Labeling Mismatch
FDA (Devices) · 2013-07-31
- HighStryker Recalls Mislabeled Intracardiac Ultrasound Catheters Due to Expiration Date Error
FDA (Devices) · 2021-02-03
- HighStryker Target Nano Coils Recalled for Manufacturing Defect
FDA (Devices) · 2016-07-20
- ModerateStryker Neurovascular Recalls Guider Softip XF Guide Catheters
FDA (Devices) · 2016-11-09
- HighStryker AXS Vecta 71 Aspiration Catheter Recall for Breakage Risk
FDA (Devices) · 2020-04-08