CASHMERE SRC140408-20Recalls & reported problems
Medos International Sàrl · CASHMERE microcoil CASHMERE 14 Stretch Resistant Coil 4mm x 8cm 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 00878528004165), received between Jun 4, 2021 and Jun 4, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2021Stretched; Difficult to Advance; Stretched; Difficult to Advance
THE HEALTHCARE PROFESSIONAL REPORTED THE PHYSICIAN WAS PUSHING THE 4MM X 8CM CASHMERE 14 PLAT COIL (SRC14040820 / L13233) THROUGH THE CONCOMITANT MICROCATHETER WITH MUCH DIFFICULTY. WHEN THE COIL WAS REMOVED, IT HAD STRETCHED. ANOTHER CASHMERE COIL OF THE SAME SIZE WAS USED WITHOUT ANY DIFFICULTY. THERE WAS NO DELAY IN THE PROCEDURE AND NO NEGATIVE PATIENT OUTCOME REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11942717 ↗
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- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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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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