DELTAPAQ CERECYTE CDF100820-30Recalls & reported problems
Medos International Sàrl · DELTAPAQ microcoil DELTAPAQ 10 CERECYTE Coil 8mm x 20cm 190cm Contents: 1 Detachable Coil System · Class 2 · Implant
All models of DELTAPAQ CERECYTE (20)
Data updated Oct 18, 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 00878528007432), received between Aug 27, 2018 and Aug 27, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/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 18, 2026.
Most reported problems
Device problems
- Material Twisted/Bent1
- Separation Failure1
- 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 27, 2018Stretched; Separation Failure; Material Twisted/Bent; Stretched; Separation Failure; Material Twisted/Bent
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN UNSPECIFIED ANEURYSM, THE 8 MM X 20 CM DELTAPAQ (CDF10082030/C24383) THERMO-MECHANICAL COIL FAILED TO DETACH DESPITE SEVERAL ATTEMPTS. THE COIL WAS REPLACED, AND THE INTERVENTION WAS CONCLUDED. THE EMBOLIC COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THE SAME DETACHMENT CONTROL BOX (DCB) AND CONNECTING CABLE WERE USED TO DETACH SUBSEQUENT COILS. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. NEITHER A ¿LOW BATTERY¿ LIGHT NOR A ¿FAULT¿ LIGHT WAS VISUALIZED DURING THE CASE. ALL LIGHTS ILLUMINATED UPON PRESSING THE ¿POWER¿ BUTTON. THE GREEN ¿SYSTEM READY¿ LIGHT ILLUMINATED. THE DETACHMENT LIGHT ILLUMINATED AND AN AUDIBLE SIGNAL BEEPED DURING THE DETACHMENT CYCLE. THE CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE COIL DELIVERY SYSTEM WAS HANDLED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7818409 ↗
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- 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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