CEREPAK FREEFORM XCR120620Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704083726), received between Oct 23, 2024 and Oct 23, 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 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2024Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ARTERIOVENOUS MALFORMATION PROCEDURE, THE 6MM X 20CM CEREPAK FREEFORM XTRASOFT (XCR120620 / 31218777) DID NOT DETACH. IT WAS REPORTED THAT ¿SYSTEM WAS ALL STRAIGHT AND IN LINE DURING DETACHMENT.¿ TWO ATTEMPTS WERE MADE TO DETACH VIA THE CEREPAKTM DETACHMENT HANDLE (MDH1 / 102109430). THEN MANUAL DETACHMENT WAS MADE WITHOUT THE HANDLE. DURING THE FINAL ATTEMPT, THE WIRE WAS PUT TO 90-DEGREE BETWEEN MECHANICAL DETACHMENT INDICATORS WHICH WAS ALSO UNSUCCESSFUL. WHEN FINALLY PULLING THE COIL BACK INTO THE MICROCATHETER (UNSPECIFIED BRAND), THE PHYSICIAN ¿DID FEEL A SNAP AND THEN THE COIL DETACH, BUT [IT] WAS NOT IN THE TARGET LOCATION.¿ THE PHYSICIAN WAS ABLE TO REMOVE THE WHOLE SYSTEM TO ENSURE THE COIL WAS NOT LEFT BEHIND. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 22-OCT-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE LOCATION OF THE TARGETED AVM IS NOT KNOWN. THE LOT NUMBER OF THE DETACHMENT HANDLE IS 102109430. THE INFORMATION INDICATED THAT MANUAL ATTEMPT WAS MADE ONCE. THE COIL BECAME DETACHED AS IT WAS BEING PULLED BACK INTO THE MICROCATHETER. THE COIL WAS NOT STRETCHED NOR DID IT BECOME SEPARATED INTO TWO OR MORE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517024 ↗