FDA Device recall Z-2168-2016
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M0035431510 Neurology: Target Detachable Coils are intended to endo…
- FDA Device
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M0035431510 Neurology: Target Detachable Coils are intended to endo… by Stryker Neurovascular, citing 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 resista….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2168-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-06 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Neurovascular |
| Distribution | US |
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.
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.
Identifiers
| code_info | MODEL Number: M0035431510; Lot Number/Expiration Date: 18581295 30-Sep-18 18800256 31-Jan-19 18775373 31-Dec-18…MODEL Number: M0035431510; Lot Number/Expiration Date: 18581295 30-Sep-18 18800256 31-Jan-19 18775373 31-Dec-18 18744204 30-Nov-18 18812788 31-Jan-19 18607578 30-Sep-18 18602655 30-Sep-18 19003141 30-Apr-19 18935435 31-Mar-19 18923481 31-Mar-19 18953907 31-Mar-19 18883412 28-Feb-19 18852906 28-Feb-19 19056331 31-May-19. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2168-2016%22
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