Stryker Neurovascular Recalls Expired Target Detachable Coils
Stryker Neurovascular is recalling Target Detachable Coils shipped to US customers beyond their expiration date.
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 does not report any illnesses, injuries, or hospitalizations. The hazard is limited to the use of expired medical devices, which fits the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Stryker Neurovascular is recalling specific units of Target Detachable Coils. The recall involves the Target 360 Standard 12mm x 30cm model, specifically Model M0035461230, Lot number 13817326, with an expiration date of October 2013.
The reason for the recall is that units of GDC 360 coils, Target coil, and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. The distribution was limited to the states of Virginia, New Hampshire, Ohio, and Texas.
Healthcare facilities and customers who received these specific expired units should stop using them and contact Stryker Neurovascular for instructions on return or replacement.
The recalled product
- Product
- Target 360 Standard 12mm x 30cm; Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Target Detachable Coils are indicated for endovascular embolization of: "…
- Manufacturer
- Stryker Neurovascular
- Hazard
- Affected units
- 1
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 (3)
- Model M0035461230
- Lot number: 13817326
- Exp. Oct 2013.
Distribution
Part of a larger recall action
This product is one of 5 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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