TARGET M0035461230Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252192503), received between Dec 16, 2022 and Jan 4, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 4, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING THE LEFT PCOMA ANEURYSM CASE, THE PHYSICIAN PREPARED A MICROCATHETER TO FRAME THE SUBJECT COIL. WHILE INSERTING THE SUBJECT COIL INTO THE ANEURYSM, IT GOT STRETCHED. ON WITHDRAWAL, THE SUBJECT COIL WAS FOUND FRACTURED. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16094108 ↗MalfunctionDec 16, 2022Premature Separation; Premature Separation
IT WAS REPORTED THAT DURING THE LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM PROCEDURE, PHYSICIAN PREPARED AND INSERTED THE SUBJECT COIL. WHILE ADJUSTING THE POSITION OF THE SUBJECT COIL, IT DETACHED UNEXPECTEDLY HALF IN THE MICROCATHETER AND HALF IN THE ANEURYSM. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15993486 ↗
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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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