FDA Device recall Z-2167-2016
Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL Number:M0035431030 Neurology: Target Detachable Coils are intended to endova…
- 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 MM X 3 CM MODEL Number:M0035431030 Neurology: Target Detachable Coils are intended to endova… 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-2167-2016 |
| 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 MM X 3 CM MODEL Number:M0035431030 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: M0035431030; Lot Number/Expiration Date: 18801491 31-Jan-19 18757273 31-Dec-18 18709428 30-Nov-18…MODEL Number: M0035431030; Lot Number/Expiration Date: 18801491 31-Jan-19 18757273 31-Dec-18 18709428 30-Nov-18 18602133 30-Sep-18 18523870 31-Jul-18 18802806 31-Jan-19 18664601 31-Oct-18 18569137 31-Aug-18 18517839 31-Jul-18 18486090 31-Jul-18 18842022 31-Jan-19 18651923 31-Oct-18 18651865 31-Oct-18 18607288 30-Sep-18 18518071 31-Jul-18 18774611 31-Dec-18 18762227 31-Dec-18 18637042 31-Oct-18 18564861 31-Aug-18 18843756 28-Feb-19 18842889 31-Jan-19 18781019 31-Jan-19 18651981 31-Oct-18 18546861 31-Aug-18 18447942 30-Jun-18 18830688 31-Jan-19 18815198 31-Jan-19 18814328 31-Jan-19 18736978 30-Nov-18 18592210 30-Sep-18 18517955 31-Jul-18 18414488 31-May-18 18829659 31-Jan-19 18583312 31-Aug-18 18984903 30-Apr-19 19050397 31-May-19 18883354 28-Feb-19 18911821 31-Mar-19 19041285 30-Apr-19 18944244 31-Mar-19 18922785 31-Mar-19 18902333 28-Feb-19 18911418 31-Mar-19 18857263 28-Feb-19 18973207 30-Apr-19 19041807 30-Apr-19 19065916 31-May-19 1 |
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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-2167-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.