CEREPAK HELIFORM XHE120204Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704083931), received between Nov 18, 2024 and Jun 18, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 2, 2025Class IOpen, 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.

• MalfunctionJun 18, 2025Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF THE MIDDLE MENINGEAL ARTERY (MMA), A HELIFORM XSFT XL 2MM X 4 CM COIL (XHE120204, 31434959) WAS USED THROUGH A PLATO 17 160CM. THE MECHANICAL DETACHMENT HANDLE (MDH1, LOT UNKNOWN) WAS USED FOR THE FIRST DETACHMENT ATTEMPT. AFTER THE FAILED DETACHMENT ATTEMPT WITH THE HANDLE, THE MANUAL BREAK WAS USED WHICH ALSO FAILED. THE COIL WAS REMOVED SUCCESSFULLY. NO PATIENT HARM OR DELAY OF CARE CAME FROM THIS DETACHMENT FAILURE. THE LEFT MMA WAS SUCCESSFULLY EMBOLIZED WITH THE FIRST TWO CEREPAK COILS. MILD TORTUOSITY WAS NOTED IN THE LEFT EXTRACRANIAL INTERNAL CAROTID ARTERY (LECA) AND THE LEFT MIDDLE MENINGEAL ARTERY. ADDITIONAL EVENT INFORMATION RECEIVED ON 02-JUN-2025 INDICATED THAT THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE WAS NO DAMAGE NOTED TO THE EMBOLIC COIL OR ANY DEVICE COMPONENT. THERE WERE NO PROCEDURAL ELAY/PROLONGATION DUE TO THE EVENT. IT WAS NOTED THAT THE CAUSE OF THE FAILURE TO DETACH IS UNKNOWN. THERE WERE TWO SUCCESSFUL COIL DETACHMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282663 ↗
• MalfunctionNov 18, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A VERY TORTOUS ANTERIOR CEREBRAL ARTERY (ACA), THE DOCTOR WAS UNABLE TO DETACH 3 COILS: FREEFORM MINI 1.5MM X 3CM (MCR091530, 31218790), FREEFORM MINI 1.5MM X 3CM (MCR091530, 31136144) AND A HELIFORM XSFT XL 2MM X 4 CM (XHE120204, 31317932). EACH COIL WAS ATTEMPTED INITIALLY WITH THE 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 20706693 ↗