FDA Device recall Z-2181-2016
Target Detachable Coils: TARGET HELICAL NANO 2MM X 6CM MODEL Number:M0035452060 Neurology: Target Detachable Coils are intended to endovasc…
- 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 2MM X 6CM MODEL Number:M0035452060 Neurology: Target Detachable Coils are intended to endovasc… 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-2181-2016 |
| 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 2MM X 6CM MODEL Number:M0035452060 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:M0035452060; Lot Number/Expiration Date: 18777380 31-Dec-18 18538894 31-Aug-18 18726354 30-Nov-18 1…MODEL Number:M0035452060; Lot Number/Expiration Date: 18777380 31-Dec-18 18538894 31-Aug-18 18726354 30-Nov-18 18830541 31-Jan-19 18802659 31-Jan-19 18776332 31-Dec-18 18499021 31-Jul-18 18743910 30-Nov-18 18725944 30-Nov-18 18454649 30-Jun-18 18794568 31-Jan-19 18538832 31-Aug-18 18829512 31-Jan-19 18801344 31-Jan-19 18709049 30-Nov-18 18693095 30-Nov-18 18499207 31-Jul-18 19032899 30-Apr-19 19047487 31-May-19 18852469 28-Feb-19 18954631 31-Mar-19 18906669 28-Feb-19 18877336 28-Feb-19 19037939 31-May-19 18973118 30-Apr-19 18899998 28-Feb-19 18900840 28-Feb-19 19046456 31-May-19 18972772 30-Apr-19 18955537 31-Mar-19 19005724 30-Apr-19 18935230 31-Mar-19 18925282 31-Mar-19 18876468 28-Feb-19 19032992 30-Apr-19. |
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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-2181-2016%22
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