DELTAPAQ CERECYTE CDF100256-30Recalls & reported problems
Medos International Sàrl · DELTAPAQ microcoil DELTAPAQ 10 CERECYTE Coil 2.5mm x 6cm 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528007142), received between Aug 8, 2019 and Dec 16, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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 Deformation1
- Stretched1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2019Material Deformation; Material Deformation
AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION, A 2.5MMX6CM DELTAPAQ CERE COIL (CDF10025630, C40100) FAILED TO RESHEATH. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME OF REPORTING. BASED ON THE DEVICE ANALYSIS, THE EMBOLIC COIL WAS FOUND DAMAGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9475021 ↗MalfunctionAug 8, 2019Stretched; Stretched
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 2.5MMX6CM DELTAPAQ CERE (CDF10025630, C40100), A 3MMX6CM DELTAPAQ CERECYTE (CDF10030630, S14317) AND A 5MMX10CM DELTAPAQ CERE (CDF10051030, S11295) WERE NOT ABLE TO ADVANCE NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COILS AND MICROCATHETER (MC) AT THE SAME TIME. AFTER INSPECTION IT TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8874305 ↗
Other DEVICE, NEUROVASCULAR EMBOLIZATION devices
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- Penumbra System SCH1Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION295 reports
- 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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