CEREPAK HELIFORM SHD180415Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704083474), received between Apr 4, 2024 and Dec 10, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, IN A VERY LARGE BASILIAR ANEURYSM, THE PHYSICIAN WAS UNABLE TO DETACH A HELIFORM XL 4MM X 15 CM COIL (SHD180415, 31098462) AND A UNIFORM 4MM X 11.5 CM COIL (FCX100412, 31207070). EACH COIL WAS ATTEMPTED INITIALLY WITH A MECHANICAL DETACHMENT HANDLE (MDH1, LOT UNKNOWN). AFTER THAT WAS UNSUCCESSFUL, THE MANUAL BREAK WAS ATTEMPTED WITHOUT SUCCESS. EACH COIL WAS TAKEN OUT OF THE ANEURYSM WITHOUT ISSUES AND ANOTHER COIL WAS USED WITH THE SAME MICROCATHETER (PLATO 17 STRAIGHT). WITH EACH COIL, THE MICROCATHETER OUTSIDE THE BODY WAS STRAIGHT. NO NEGATIVE IMPACT ON PATIENT AND NO SIGNIFICANT DELAY IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895311 ↗
• MalfunctionApr 4, 2024Material Separation; Separation Failure; Material Separation; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VESSEL SACRIFICE PROCEDURE TARGETING THE RIGHT VERTEBRAL ARTERY TO LIMIT BLOOD FLOW TO A TUMOR, THE SECOND COIL THE PHYSICIAN TRIED TO IMPLANT, A 2MM X 8CM CEREPAK HELIFORM XTRASOFT (XHE120208 / 31162599) DID NOT DETACH. THE PHYSICIAN COULD NOT FIND THE DETACHMENT MARKER ON FLUORO IMAGING. THE MARKER MAY HAVE BEEN ADVANCED TOO FAR OUT OF THE CONCOMITANT MICROCATHETER, A PNOVUS¿ 17 MICROCATHETER (WALLABY-PHENOX), AND INTO THE COIL MASS, OR THE MARKER COULD HAVE BEEN TOO PROXIMAL AND OFFSCREEN. IT WAS REPORTED THAT THE PHYSICIAN WAS ADAMANT THAT THIS COIL DID NOT HAVE ANY DETACHMENT MARKER. THE PROXIMAL END OF THE HYPOTUBE BROKE OFF DURING MANUAL BREAK AND ALSO SHEARED THE WIRE. THE PHYSICIAN ATTEMPTED AND FAILED TO DETACH THE PULL WIRE WITH FORCEPS. THE PHYSICIAN REMOVED THE NON-DETACHED COIL. LATER IN THE PROCEDURE, ANOTHER COIL, A 4MM X 15CM CEREPAK HELIFORM XL (SHD180415 / 31098462) ALSO DID NOT DETACH. THE PROXIMAL END OF THE HYPOTUBE BROKE OFF DURING MANUAL BREAK AND AGAIN SHEARED OFF THE WIRE AT THE BREAKPOINT. THE PHYSICIAN ATTEMPT AND FAILED TO DETACH THE PULL WIRE WITH FORCEPS. THE PHYSICIAN REMOVED THE NON-DETACHED COIL. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19046161 ↗