Recall Z-2174-2016— Stryker Neurovascular
Class II · Terminated
Class II FDA medical device recall by Stryker Neurovascular, initiated 2016-06-06, terminated 2017-03-03. It names 2 FDA 510(k) clearances: K153658, K113412. Product: Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.. Reason: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching..
- Recalling firm
- Stryker Neurovascular
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-06
- Terminated
- 2017-03-03
- Firm location
- Fremont, CA, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Reason for recall
Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
Data sourced from openFDA. This site is unofficial and independent of the FDA.