Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.
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 involves a medical device defect that compromises intended performance (stretch resistance) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Neurovascular is recalling specific units of Target Detachable Coils, including the TARGET 360 NANO 1 MM X 3 CM model. The recall affects 45,302 units worldwide, with 8,188 units distributed in the United States. The products were distributed globally, including in the US, Australia, Canada, and numerous European and Asian countries.
The recall was initiated because some units do not have the intended stretch resistance. Stryker Neurovascular identified that the sutures inside the coil, which provide this resistance, may have been damaged during the manufacturing process. This defect can lead to an increased occurrence of coil stretching.
Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. The source text does not specify instructions for consumers or healthcare providers regarding the immediate handling of these devices, nor does it report any specific injuries or illnesses associated with the defect.
The recalled product
- Product
- Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
- Manufacturer
- Stryker Neurovascular
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 28 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 28 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 · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateStryker Neurovascular Recalls Expired Target Detachable Coils
FDA (Devices) · 2014-12-10
- ModerateStryker GDC 360 Detachable Coils Recalled for Incorrect Device Formulation
FDA (Devices) · 2016-04-27
- ModerateStryker GDC 360 Coils Recalled for Expiration Date Violations
FDA (Devices) · 2014-12-10
- ModerateStryker GDC 360 Detachable Coils Recalled for Incorrect DFU Packaging
FDA (Devices) · 2016-04-27
- ModerateStryker Precision Neuro Drill Recall Due to Missing Notches
FDA (Devices) · 2014-06-18
- ModerateStryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates
FDA (Devices) · 2013-12-25