CEREPAK HELIFORM SHD180520Recalls & reported problems
Cerenovus, Inc. · CEREPAK HELIFORM XL Detachable Coil Delivery System Length - 190 cm Coil Diameter - 5 mm Coil Length - 20 cm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704083481), received between Dec 4, 2024 and Dec 4, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Failure” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Oct 2, 2025Open, Classified
Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.
Z-0434-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Separation Failure1
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.
MalfunctionDec 4, 2024Separation Failure; Separation Failure
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TO RETREAT AN ANEURYSM DUE TO RESIDUAL FILLING ON FOLLOW-UP ANGIOGRAPHY, THE MICROCATHETER WAS NAVIGATED INTO THE ANEURYSM AND A 5MM X 20CM CEREPAK HELIFORM XL (SHD180520 / 31228059) WAS INTRODUCED. AN ATTEMPT TO DETACH THE COIL WAS MADE WITH THE DETACHMENT HANDLE (MDH1 / 102109430) WIRE WITH SLOW ACTUATION TO TRANSLATE THE PULL WIRE. THE CEREPAK HELIFORM COIL DID NOT DETACH, AND THE PULL WIRE WAS NOT VISIBLY ELONGATED. DETACHMENT WAS ATTEMPTED AGAIN WITH THE DETACHMENT HANDLE AND THE PULL WIRE WAS CONFIRMED TO BE ELONGATED POST-ACTUATION. WHEN THE COIL PUSHER WAS BEING REMOVED, IT WAS NOTED THAT THE COIL WAS NOT DETACHED. THE PHYSICIAN SWITCHED TO THE MANUAL BREAK METHOD. THE OUTER TUBE WAS SNAPPED AT THE SCORE MARK WITH THE PULL WIRE STILL INTACT. LIGHT TENSION WAS USED TO ACTUATE BUT THE PULL WIRE STRETCHED. THE COIL WAS NOT DETACHED AND WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING TARGET COILS (STRYKER). THE PROCEDURE WAS DELAYED BY 10 MINUTES, BUT IT WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 25-NOV-2024, ADDITIONAL INFORMATION WAS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20849033 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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