FDA Device recall Z-2552-2026
INZONE DETACHMENT SYSTEM, REF: M00345100950
- FDA Device
- Class II
- ongoing
- Published 2026-07-01
On 2026-07-01 the FDA classified a Class II recall of INZONE DETACHMENT SYSTEM, REF: M00345100950 by Stryker Neurovascular, citing embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2552-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-06 |
| Published | 2026-07-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Stryker Neurovascular |
| Distribution | US |
Product
INZONE DETACHMENT SYSTEM, REF: M00345100950
Reason
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.
Identifiers
| code_info | UDI-DI: 04546540697950. Lots: WMP133638, WMP133871, WMP133872, WMP133988, WMP133989, WMP134016, WMP134132, WMP134133, W…UDI-DI: 04546540697950. Lots: WMP133638, WMP133871, WMP133872, WMP133988, WMP133989, WMP134016, WMP134132, WMP134133, WMP134234, WMP134235, WMP134255, WMP134256, WMP134380, WMP134381, WMP134432, WMP134433, WMP134518, WMP134519, WMP134609, WMP134610, WMP134794, WMP134795, WMP134939, WMP134940, WMP135187, WMP135243, WMP135302, WMP135314, WMP135354, WMP135355, WMP135387, WMP135417, WMP135473, WMP135475, WMP135491, WMP135492, WMP135623, WMP135720, WMP135727, WMP135807, WMP135865, WMP135897, WMP136084, WMP136107, WMP136190, WMP136200, WMP136611, WMP136642, WMP136736, WMP136748, WMP136852, WMP136894, WMP136985 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2552-2026%22
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