Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, increasing the risk of coil stretching.
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, and the hazard involves a structural defect in a medical device that could lead to device malfunction (coil stretching) 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, specifically the Target Helical Nano 2.5mm x 4cm model (Model Number M0035452540). 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 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 units are identified by specific lot numbers and expiration dates, including lots 18440351, 18539018, 18439805, 18519562, 18468754, 18922401, 19060307, 18970593, 18898116, 19034354, and 18875384. These coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Healthcare providers and patients should contact Stryker Neurovascular for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL Number:M0035452540 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:M0035452540
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.
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