CEREPAK HELIFORM SHD181445Recalls & reported problems
Cerenovus, Inc. · CEREPAK HELIFORM XL Detachable Coil Delivery System Length - 190 cm Coil Diameter - 14 mm Coil Length - 45 cm · Class 2 · Implant
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 10886704083559), received between Dec 28, 2023 and Dec 28, 2023 — 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 28, 2023Separation Failure; Separation Failure
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING A LEFT PERI-OPHTHALMIC ANEURYSM WITH THE CEREPAK COIL SYSTEM, THE FIRST COIL INTRODUCED WAS DETACHED WITHOUT ISSUE. THE SECOND COIL WAS A 14MM X 45CM CEREPAK HELIFORM XL (SHD181445 / 31154801) WAS INTRODUCED INTO THE ANEURYSM WITHOUT ISSUE. THE PHYSICIAN FOLLOWED TRAINING PROTOCOL BUT THE COIL WOULD NOT DETACH. THE COIL WAS REMOVED SAFELY; IT HAS BEEN SAVED FOR INVESTIGATION. THE FACILITY EMPLOYS THE MANUAL BREAK DETACHMENT METHOD. IT WAS REPORTED THAT THERE WAS NO DELAY TO THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO NEGATIVE PATIENT IMPACT. ON (B)(6), 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE CONCOMITANT MICROCATHETER USED WAS THE SL-10® 45° MICROCATHETER (STRYKER). THE SAME MICROCATHETER WAS USED WITH THE FIRST COIL AND ALL SUBSEQUENT COMPETITOR COILS TO COMPLETE THE PROCEDURE. WHEN THE 14MM X 45CM HELIFORM COIL WAS REMOVED, NO STRETCHING WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH TWO MORE COMPETITOR COILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18410639 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.