CASHMERE CERECYTE CRC141025-30Recalls & reported problems
Medos International Sàrl · CASHMERE microcoil CASHMERE 14 CERECYTE Coil 10mm x 25cm 190cm Contents: 1 Detachable Coil System · Class 2 · Implant
All models of CASHMERE CERECYTE (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878528004714), received between Feb 15, 2018 and Feb 15, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Positioning Failure” (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 18, 2026.
Most reported problems
Device problems
- Positioning Failure1
- Premature Activation1
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.
InjuryFeb 15, 2018Positioning Failure; Premature Activation; Positioning Failure; Premature Activation
A REPORT WAS RECEIVED THAT DURING A FLOW DIVERTER ASSISTED COIL EMBOLIZATION OF AN INCIDENTAL RIGHT INTERNAL CAROTID ARTERY ANEURYSM, THE 10 MM X 25 CM CASHMERE 14 CERECYTE THERMO-MECHANICAL COIL (CRC14102530/S00006) WOULD NOT DETACH AFTER AT LEAST FIVE ATTEMPTS WERE MADE. THE COIL THEN PREMATURELY DETACHED IN THE ¿CENTRAL TO DISTAL THIRD¿ OF THE UNSPECIFIED MICROCATHETER DURING AN ATTEMPT TO RETRIEVE THE COIL. THERE WAS A RISK OF MISPLACING THE COIL BECAUSE "REMOVING VIA MICROCATHETER WAS NO LONGER POSSIBLE". THE PHYSICIAN SUBSEQUENTLY PUSHED THE DETACHED COIL INTO THE ANEURYSM. THE POSITION OF THE PLACED COIL WAS DEEMED ACCEPTABLE. THE COIL DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THIS EVENT. THE PROCEDURE WAS DELAYED FIVE TO TEN MINUTES. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO ISSUE ASSOCIATED WITH THE ENPOWER DETACHMENT CONTROL BOX (DCB000005-00/F66118) OR THE ENPOWER CONNECTING CABLE (CCB000157-00/LOT UNK) USED IN THE CASE. THE SAME DCB AND CONNECTING CABLE WERE UTILIZED TO DETACH SUBSEQUENT COILS. A TOTAL OF TEN COILS WERE PLACED IN THE PROCEDURE, FOUR OF WH
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7275668 ↗
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- RUBY Coil RBY4C0860-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION276 reports
- Smart Coil 400SMTHXSFT0208Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION165 reports
- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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