TARGET M0035473100Recalls & reported problems
Stryker Corporation · 360 Soft Detachable Coil · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252239475), received between Mar 19, 2019 and Apr 1, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Migration” (2 reports).
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
Most reported problems
Device problems
- Migration2
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2025Migration; Migration
IT WAS REPORTED THAT DURING DEPLOYMENT OF A COIL, THE SUCCESSFULLY DETACHED SUBJECT COIL GOT ENTANGLED WITH THE MICROCATHETER AND CAME OUT WHEN THE MICROCATHETER WAS PULLED BACK. THE SUBJECT DEVICE WAS WITHDRAWN AND WAS REPLACED WITH A DIFFERENT COIL AND CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 10 MINS. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21749032 ↗InjuryMar 19, 2019Migration; Premature Separation; Migration; Premature Separation
IT WAS REPORTED THAT COIL EMBOLIZATION PROCEDURE OF ANEURYSM LOCATED ON THE ANTERIOR COMMUNICATING ARTERY (ACOM), IT WAS DIFFICULT TO INTRODUCE THE LAST COIL (SUBJECT DEVICE) INTO THE ANEURYSM. THE COIL FAILED TO BE COMPLETELY DEPLOYED AFTER 5CM OF ITS LENGTH. WHILE TRYING TO WITHDRAW THE COIL, THE COIL STRETCHED, DETACHED, AND CRUMPLED WITHIN THE CAROTID BIFURCATION. IT TOOK SOME TIME UNTIL THE PHYSICIAN WAS ABLE TO WITHDRAW THE COIL OUT OF THE ANEURYSM AND OUT OF THE PATIENT¿S BODY BY USING A STENT RETRIEVER. THE PROCEDURE WAS COMPLETED WITH ANOTHER COIL OF THE SAME SIZE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8434713 ↗
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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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