HELIPAQ CERECYTE CHE100720-30Recalls & reported problems
Medos International Sàrl · HELIPAQ microcoil HELIPAQ 10 CERECYTE Coil 7mm 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 00878528000525), received between Jan 19, 2021 and Jan 19, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2021Difficult to Advance; Difficult to Advance
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, THE PHYSICIAN DESCRIBED DIFFICULTY/RESISTANCE PUSHING BOTH A 7MMX20CM HELI 10 TP CERE COIL (CHE10072030, L15303) OUT OF A RAPID TRANSIT DUAL MARKER 150CM MICROCATHETER (601251X, LOT UNKNOWN). THE COIL WAS NOT DEPLOYED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT; THE DEVICES WERE ABLE TO MOVE. THE RESISTANCE WAS FIRST NOTICED INSIDE THE MICROCATHETER (MC), DISTAL TIP AS COIL EXITED MC. THE COIL DELIVERY SYSTEM WAS REMOVED THROUGH THE MC. THE EVENT DID NOT RESULT IN A LOSS OF CEREBRAL TARGET POSITION. THE MC WAS NOT DAMAGED DURING MANIPULATION OF THE COIL OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THERE WAS NOTHING NOTED OBSTRUCTING THE MICROCATHETER. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING COIL ADVANCEMENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE ANALYSIS OF THE HELI 10 TP CERE, 7MMX20CM RECEIVED, THE EMBOLIC COIL WAS FOUND IN A STRETCH CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11195766 ↗
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