TARGET M0035464100Recalls & reported problems
Stryker Corporation · 360 Standard Detachable Coil · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540676221), received between Oct 26, 2016 and Oct 26, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Break1
- Migration or Expulsion of Device1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 26, 2016Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device
IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE THAT THE SUBJECT DEVICE WAS OBSERVED TO BE BROKEN. THE PHYSICIAN DECIDED TO RETRACT THE COIL TOGETHER WITH THE MICROCATHETER, BUT HALF OF THE COIL REMAINED IN THE ARTERIAL LUMEN. MEDICAL INTERVENTION WAS PERFORMED THROUGH A DOUBLE ANTIAGGREGATION PROCEDURE AND A STENT WAS DEPLOYED TO KEEP THE COIL AGAINST THE ARTERIAL WALL. THE COIL WAS MAINTAINED IN PLACE AGAINST THE ARTERIAL WALL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6059515 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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