INZONE M00345100950Recalls & reported problems
Stryker Corporation · DETACHMENT SYSTEM · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540697950), received between Aug 3, 2020 and Feb 9, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Expulsion” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Apr 6, 2026Open, Classified
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.
Z-2552-2026 · Root cause: Component design/selection · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Expulsion1
Patient problems
- Insufficient Information1
- Intracranial Hemorrhage1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2026
FROM STAFF: S [SITUATION]: MMA [MIDDLE MENINGEAL ARTERY] EMBOLIZATION BEING COMPLETED. A STRYKER COIL DETACHER WAS OPENED LOT # WMP137646 WAS OPENED AND THE PULL TAB WAS NOT THERE, AND THE DEVICE WOULD NOT TURN ON. B [BACKGROUND]: A STRYKER COIL NEEDED TO BE USED TO COMPLETE THE PROCEDURE TO PREVENT FURTHER GROWTH OF SDH [SUBDURAL HEMATOMA]. A [ASSESSMENT]: A DEVICE MALFUNCTION. A SECOND DEVICE WAS OPENED AND WAS SUCCESSFUL. R [RECOMMENDATION]: REP MAY WANT TO BE NOTIFIED TO LET THEM KNOW THERE WAS A MALFUNCTION IN PRODUCT. A SECOND COIL DETACHER WAS OPENED AND DID WORK.
Patient problems: Insufficient Information
MAUDE report 24290915 ↗InjuryAug 3, 2020Expulsion; Adverse Event Without Identified Device or Use Problem; Expulsion; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING PROCEDURE FOR COILING OF ANEURYSM, SUBJECT COIL WAS NOTED TO BE UNABLE TO DETACH. THE DETACHMENT SYSTEM FAILED TO INDICATE THAT THE SUBJECT COIL DID NOT DETACH SUCCESSFULLY. ONE SUBJECT COIL LOOP REMAINED IN VESSEL. PATIENT EXPERIENCED ICB (INTRACRANIAL BLEEDING) AND SAH (SUBARACHNOID HEMORRHAGE). THE PROCEDURE WAS COMPLETED SUCCESSFULLY, NO FURTHER INFORMATION AVAILABLE.
Patient problems: Intracranial Hemorrhage
MAUDE report 10360309 ↗
Other Device, Vascular, for Promoting Embolization devices
- POD RBYPOD8-APenumbra, Inc. · Device, Vascular, For Promoting Embolization195 reports
- CEREPAKTM MDH1Cerenovus, Inc. · Device, Vascular, for Promoting Embolization1 recall72 reports
- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.