HELIPAQ CERECYTE CHE180620-30Recalls & reported problems
Medos International Sàrl · HELIPAQ microcoil HELIPAQ 18 CERECYTE Coil 6mm x 20cm 190cm Contents: 1 Detachable Coil System · Class 2 · Implant
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 00878528000761), received between Jul 9, 2018 and Jul 9, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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 Fragmentation1
- Premature Activation1
- Unraveled Material1
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.
MalfunctionJul 9, 2018Material Fragmentation; Premature Activation; Unraveled Material; Material Fragmentation; Premature Activation; Unraveled Material
THE HEALTHCARE PROFESSIONAL REPORTED THE HELIPAQ 18 CERECYTE COIL 6 MM X 20 CM (CHE18062030 / C39043) WAS THE THIRD COIL USED DURING THE EMBOLIZATION PROCEDURE TO TREAT AN ENDOVASCULAR LEAK IN THE (B)(6) MALE PATIENT POST-ENDOVASCULAR REPAIR OF AN AORTIC ANEURYSM. THE FIRST COIL WAS DEPLOYED, THE SECOND COIL WAS RETRIEVED. THE HELIPAQ COIL WAS ADVANCED IN THE DEPLOYMENT MICROCATHETER (HYDROPHILIC PROGREAT .021 IN MICRO 2.4-2.9FR .022 IN 130 CM MARKER BAND) VIA THE ACCESSED L1 ARTERY TO THE SITE WHERE DEPLOYMENT WAS DESIRED WITHIN THE AORTIC ANEURYSM SAC; THE COIL WAS DETERMINED TO BE TOO LONG AND THE PHYSICIAN MADE THE DECISION TO RETRACT THE COIL RATHER THAN TO DEPLOY IT. THERE WAS RESISTANCE BETWEEN THE DEPLOYMENT MICROCATHETER AND THE HELIPAQ 18 CERECYTE COIL DURING THE RETRACTION OF THE COIL THROUGH THE DEPLOYMENT MICROCATHETER. THE RESISTANCE ENCOUNTERED BY THE HELIPAQ 18 CERECYTE COIL WAS REPORTED TO BE THE SAME AMOUNT OF RESISTANCE THAT THE SECOND RETRIEVED COIL ENCOUNTERED THROUGH THE LONG TORTUOUS PATH THAT THE CATHETER FOLLOWED. IT BECAME APPARENT THAT THE COIL WAS NOT RETRACTING DESPITE PULLING ON THE DEPLOYMENT WIRE. THE COIL APPEARED TO UNRAVEL. THE PHYSICIAN DECIDED T
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7670771 ↗
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- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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