DELTAPAQ CERECYTE CDF100616-30Recalls & reported problems
Medos International Sàrl · DELTAPAQ microcoil DELTAPAQ 10 CERECYTE Coil 6mm x 16cm 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 00878528007357), received between Oct 21, 2020 and Oct 21, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Separation” (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
- Premature Separation1
- 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.
MalfunctionOct 21, 2020Stretched; Premature Separation; Stretched; Premature Separation
AS REPORTED BY THE FIELD, DURING A TRANSCATHETER STENT ASSISTED EMBOLIZATION OF AN INTRACRANIAL ANEURYSM, THE COIL OF A 6MMX16CM DELTAPAQ CERE (CDF10061630, C40543) COULDN¿T CROSS THE PROWLER SELECT 14 MICROCATHETER (MC). THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT DURING ADVANCEMENT TO THE TARGET AREA, THE COIL DELIVERY SYSTEM WAS NOT ABLE TO MOVE DUE TO THE RESISTANCE BEFORE ARRIVING AT THE TIP OF THE MC, THE RESISTANCE WAS 10CM NEAR THE TIP OF MC. THERE WAS NO DAMAGE TO THE COIL OR THE DELIVERY SYSTEM DUE TO THE RESISTANCE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED. THE DEVICE WAS ABLE TO BE REMOVED THROUGH THE MC. THE MC WAS LEFT AT THE TARGET, THEREFORE, THERE WAS NO LOSS OF CEREBRAL TARGET POSITION. AFTER THE COMPLAINT COIL WAS REMOVED, A NEW COMPETITOR¿S COIL CROSSED THE MC SUCCESSFULLY. THE DEVICE NOR THE MICROCATHETER KINKED OR BENT PRIOR TO THE RESISTANCE OR NOTED AFTER REMOVAL FROM THE PATIENT. BASED ON THE DEVICE ANALYSIS, THE EMBOLIC COIL WAS FOUND MECHANICALLY DETACHED WITH A STRETCH CONDITION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10712449 ↗
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- 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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