CEREPAK FREEFORM MCR092020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704084778), received between Apr 3, 2024 and Apr 3, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Premature Separation” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2024Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT PRESENTED TO (B)(6) HOSPITAL WITH AN INTRACRANIAL HEMORRHAGE. AFTER A VERY DIFFICULT ACCESS, THE PHYSICIAN WAS ABLE TO NAVIGATE THE ANEURYSM THROUGH TORTUOUS ANATOMY. USING A HEADWAY® DUO MICROCATHETER (MICROVENTION), THE PHYSICIAN ATTEMPTED TO DEPLOY THE FIRST COIL, A 5MM X 15CM CEREPAK FREEFORM XTRASOFT (XCR120515 / 31111683). THE COIL FAILED TO DETACH WITH THE CEREPAK TM MECHANICAL DETACHMENT HANDLE (MDH1 / 102109430). MANUAL BREAK WAS ATTEMPTED WITHOUT SUCCESS. THE COIL WAS REPLACED WITH ANOTHER 5MM X 15CM CEREPAK FREEFORM XTRASOFT (XCR120515) FROM THE SAME LOT (31111683) HERE MANUAL BREAK AS THE FIRST METHOD OF DETACHMENT, AND IT WAS ALSO UNSUCCESSFUL. IT WAS REPORTED THAT AT THIS POINT, A 2MM X 2CM CEREPAK FREEFORM MINI (MCR092020 / 31177313) WAS ADVANCED. ONCE AGAIN, MANUAL BREAK WAS CHOSEN AT THE PRIMARY DETACHMENT METHOD, AND AGAIN, THE COIL DID NOT DETACH. AT THIS POINT, THE COIL WAS REMOVED AND THE PHYSICIAN NOTICED WHAT APPEARED TO BE ¿FILAMENT¿ RETAINED WITHIN THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO REMOVE [THE FILAMENT] WITHOUT INCIDENT AND THE PROCEDURE WAS MOVED FORWARD USING MICROVENTION COILS. THERE WAS NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038169 ↗