Agency classClass IIOur severity:High FDA (Devices)·Z-2168-2016·Announced 2016-07-20

Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance

Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may have reduced their stretch resistance, potentially leading to increased 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 with a structural defect (damaged sutures) that compromises its intended function (stretch resistance). Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Stryker Neurovascular is recalling specific units of Target Detachable Coils, specifically the Target Helical Nano 1.5 mm x 1 cm model (Model Number M0035431510). The recall involves 45,302 units worldwide, with 8,188 units distributed in the United States. The products were distributed nationwide in the U.S. and in numerous countries worldwide.

The recall was initiated because Stryker Neurovascular became aware that some units do not have the intended stretch resistance. The sutures inside the coil that provide this resistance may have been damaged during the manufacturing process. This defect can lead to an increased occurrence of coil stretching.

The affected lots include 18581295, 18800256, 18775373, 18744204, 18812788, 18607578, 18602655, 19003141, 18935435, 18923481, 18953907, 18883412, 18852906, and 19056331. These are medical devices 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 next steps for these specific units.

The recalled product

Product: Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M0035431510 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 — Endovascular Coils
Hazard: structural-defect
device-malfunction

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: M0035431510

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 →

Same manufacturer · Stryker Neurovascular

See all →

High
Stryker Neurovascular INZONE Detachment System battery drain
FDA (Devices) · 2026-07-01
High
Trevo Trak 21 Microcatheter Distributed with Incorrect Instructions and Labels
FDA (Devices) · 2024-10-16
High
Stryker Synchro Neuro Guidewires Recalled for PTFE Coating Damage Risk
FDA (Devices) · 2024-06-12
High
Synchro SELECT Guidewires may have PTFE coating damage
FDA (Devices) · 2024-06-12
High
Synchro2 Guidewires: PTFE coating damage from improper backloading technique
FDA (Devices) · 2024-06-12

Same hazard · structural defect