CEREPAK HELIFORM SHD180312Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704083467), received between Mar 10, 2025 and Apr 21, 2025 — 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. How this data works · Data updated Oct 13, 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 · 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.

• MalfunctionApr 21, 2025Separation Failure; Separation Failure

  AS REPORTED BY THE HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION TO A VERTEBRAL ARTERY FISTULA, THE PHYSICIAN WAS COILING THROUGH A PLATO 017 160CM MICROCATHETER (MC). INSERTED 10 COILS PREVIOUSLY. INSERTED A HELIFORM XL 3MM X 12 CM COIL (SHD180312, 31168339), DURING DETACHMENT, TRIED THE MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) BUT WAS UNSUCCESSFUL SO THE USER TURNED TO MANUAL BREAK METHOD. DURING MANUAL BREAK, PULL WIRE BROKE OFF INSIDE OF THE PUSHER TUBE, SO UNABLE TO GRASP WITH HEMOSTAT TO PULL ON THE PULL WIRE. THE COIL WAS UNABLE TO DETACH. 5 COILS WERE SUBSEQUENTLY IMPLANTED AND DETACHED WITH NO ISSUES. THERE WERE NO PROCEDURAL DELAYS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION RECEIVED ON 01-APR-2025 INDICATED THAT THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE WERE NO VISUAL DEFORMITIES ON THE COIL. THE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. IN THE PHYSICIAN'S OPINION, THERE WERE NO FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872791 ↗
• MalfunctionMar 10, 2025Stretched; Separation Failure; Stretched; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION, A HELIFORM XL 3MM X 12 CM COIL (SHD180312, 31168339) DID NOT DETACH WITH THE MECHANICAL DETACHMENT HANDLE (MDH1, UNKNOWN LOT), IT ALSO DID NOT DETACH MANUALLY. THE DOCTOR RETRIEVED THE COIL WITH NO PROBLEMS. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION RECEIVED ON 26-FEB-2025 INDICATED THAT THREE COILS WERE PREVIOUSLY IMPLANTED DURING PROCEDURE. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THREE ATTEMPTS WERE MADE WITH THE DETACHMENT HANDLE. IT WAS NOTED THAT THE PULL WIRE OF THE DEVICE WAS STRETCHED. THERE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. ADDITIONAL EVENT INFORMATION RECEIVED ON 27-FEB-2025 CONFIRMED THAT THE COIL WAS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561235 ↗