Stryker Target Nano Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, potentially causing the coils to stretch.
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. Per the rubric, risk-of-harm products where injury has not yet been reported are assigned a score of 3 (High).
Plain-English summary
Stryker Neurovascular is recalling specific units of Target Nano coils, including the Target Helical Nano 3mm x 8cm model. The recall affects 45,302 units worldwide, with 8,188 units distributed in the United States.
The recall was initiated because some units do not have the intended stretch resistance. Stryker identified that the sutures inside the coils, which provide this resistance, may have been damaged during the manufacturing process. This defect can lead to an increased occurrence of coil stretching.
The affected products were distributed worldwide, including in the United States, Australia, Canada, and numerous other countries. Specific lot numbers and expiration dates are listed in the agency's recall record. Healthcare providers and patients should consult the FDA recall notice for specific lot details and instructions on how to proceed.
The recalled product
- Product
- Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL Number:M0035453080 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
- Category
- Medical Device — Neurovascular
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)
- MODEL Number:M0035453080
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) · 2026-09-02
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- HighKnee Prosthesis Trial Recall for Manufacturing Defect
FDA (Devices) · 2026-08-12
- HighUnited Orthopedic Corp. Recalls Femoral Valgus Offset Adaptors for U2 Total Knee System
FDA (Devices) · 2026-08-12
- HighU2 Total Knee System Femoral Valgus Adaptor Recall
FDA (Devices) · 2026-08-12