HELIPAQ CERECYTE CHE100730-30Recalls & reported problems
Medos International Sàrl · HELIPAQ microcoil HELIPAQ 10 CERECYTE Coil 7mm x 30cm 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 00878528000532), received between Jul 25, 2017 and Jul 25, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Activation” (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 Activation1
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 25, 2017Premature Activation; Premature Activation
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING EMBOLIZATION OF AN ANEURYSM A HELIPAQ10 CERE, 7MM X 30 CM (CHE10073030/C30516) COIL WAS IMPEDED IN THE INTRODUCER. THE PROCEDURE WAS EMBOLIZATION OF AN ANEURYSM AT RIGHT POSTERIOR COMMUNICATING ARTERY. AFTER PLACING THE FIRST COIL IN THE ANEURYSM THE PHYSICIAN REQUESTED THE SECOND COIL, THE HELIPAQ COIL. THE TIP OF THE COIL SYSTEM WAS PLACED IN THE VALVE. AFTER UNLOCKING THE GREEN INTRODUCER, THE COIL WIRE WAS THEN ATTEMPTED TO PUSH INTO THE MICROCATHETER, HOWEVER RESISTANCE WAS EXPERIENCED. THE COIL WAS LOCKED IN THE CARRIER SHEATH. THE COIL COULD NOT BE SEEN MOVING TOWARDS THE GREEN TIP WHICH WAS IN THE VALVE, IT WAS THEN DECIDED TO SUSPEND THE PLACEMENT OF THE COIL. THE SYSTEM WAS REMOVED FROM THE VALVE AND THE WIRE THAT PUSHES THE COIL WAS REMOVED AND IT WAS VERIFIED THE COIL WAS TEMPORARILY RELEASED WITHOUT LEAVING THE SHEATH ENVELOPING THE COIL. THE PUSHER WAS EXTRACTED WHICH CAME OUT WITHOUT THE COIL, WHICH WAS LATER EXTRACTED FROM THE INSIDE OF THE SHEATH. THERE WERE NO ADVERSE EVENTS OR COMPLICATIONS. OTHER COILS WERE USED TO COMPLETE THE PROCEDURE, FIVE COILS OF DIFFERENT BRANDS WERE PLACED WITHOUT ANY DIFFICULTY. THERE WER
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6740132 ↗
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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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