CASHMERE SRC140304-20Recalls & reported problems
Medos International Sàrl · CASHMERE microcoil CASHMERE 14 Stretch Resistant Coil 3mm x 4cm 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 00878528004103), received between Aug 11, 2017 and Aug 11, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Bent” (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
- Bent1
- Physical Resistance1
- Positioning Failure1
- Premature Activation1
- Stretched1
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.
MalfunctionAug 11, 2017Bent; Positioning Failure; Premature Activation; Stretched; Physical Resistance; Bent; Positioning Failure; Premature Activation; Stretched; Physical Resistance
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF THE INTERNAL CAROTID ARTERY, THE CASHMERE COIL (SRC14030420/ P11045) FAILED TO DETACH AND THEN THERE WAS RESISTANCE DURING WITHDRAWAL AND THE COIL SEPARATED INTO TWO PIECES IN THE MICROCATHETER. THERE HAD BEEN NO RESISTANCE DURING ADVANCEMENT OF THE COIL. THE MICROCATHETER WAS REMOVED WITH THE COIL. AFTER THE FAILURE TO DETACH, THE CABLE WAS CHANGED OUT FOR ANOTHER, BUT THERE WAS STILL NO DETACHMENT. UPON REMOVING THE COIL FROM THE PATIENT, IT SEPARATED IN THE SL10 MICROCATHETER AND WAS RETRIEVED. THE SAME CABLES AND DCB WERE USED TO COMPLETE THE PROCEDURE. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN COMPLETED AND NO LOW BATTERY LIGHT WAS SEEN AND A FAULT LIGHT WAS NOT SEEN. THE GREEN SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. HERE WAS NO PATIENT DEATH OR SERIOUS INJURY AND NO ADDITIONAL MEDICAL INTERVENTION WAS NEEDED. THE PATIENT WAS IN GOOD CONDITION. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6787713 ↗
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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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