HELIPAQ CERECYTE CHE101020-30Recalls & reported problems
Medos International Sàrl · HELIPAQ microcoil HELIPAQ 10 CERECYTE Coil 10mm 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 00878528000624), received between Sep 6, 2017 and Sep 6, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Kinked” (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
- Kinked1
- Physical Resistance1
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.
MalfunctionSep 6, 2017Kinked; Physical Resistance; Kinked; Physical Resistance
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING ANEURYSM COIL EMBOLIZATION, THEY TRIED TO INSERT THE HELIPAQ (CHE10102030/ C28384) COIL, BUT IT DID NOT PASS THROUGH THE UNSPECIFIED MICROCATHETER DESPITE SEVERAL ATTEMPTS AND DURING ANALYSIS IT WAS FOUND THAT THE COIL WAS KINKED. THERE WERE NO PATIENT ADVERSE EVENTS, BUT THE PROCEDURE WAS DELAY 15 MINUTES. THE PROCEDURE WAS COMPLETED WITH A SIMILAR PRODUCT. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6847319 ↗
Other DEVICE, NEUROVASCULAR EMBOLIZATION devices
- POD RBYPODJ60-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION355 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page