CASHMERE SRC141127-20Recalls & reported problems
Medos International Sàrl · CASHMERE microcoil CASHMERE 14 Stretch Resistant Coil 11mm x 27cm 190cm Contents: 1 Detachable Coil System · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878528004066), received between Oct 13, 2016 and Oct 13, 2016 — classified as 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 13, 2016Fracture; Fracture
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE COILING PROCEDURE THE FIRST CASHMERE COIL (SRC14112720/C21941) BROKE INSIDE THE MICROCATHETER (TYPE/LOT UNKNOWN), THE MICROCATHETER WAS REMOVED ALONG WITH THE BROKEN COIL INSIDE. A NEW MICROCATHETER (LOT UNKNOWN) WAS USED TO CONTINUE WITH THE PROCEDURE. THE SECOND COMPLAINT CASHMERE COIL (SRC14111820/G15957) WAS THE 6TH COIL BEING POSITIONED INSIDE THE ANEURYSM; THERE WERE 5 CMS OF THE COIL REMAINING OUTSIDE THE ANEURYSM WHEN THE PHYSICIAN DECIDED TO REMOVE THE COIL. WHEN BEING REMOVED THE COIL BROKE AT THE DETACHMENT PART AND THE COIL COULD NO LONGER BE REMOVED, PART OF THE COIL REMAINS PROTRUDING FROM THE ANEURYSM. POST-PROCEDURE PATIENT WAS REPORTED TO BE STABLE AND RECOVERING IN ICU.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6025984 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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