Official recall record
INZONE DETACHMENT SYSTEM, REF: M00345100950
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-04-06
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 04546540697950
- Brand on record
- Stryker Neurovascular
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.
Record last checked against the registry on 2026-09-16.
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