HELIPAQ CERECYTE CHE180204-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878528000709), received between Jan 28, 2020 and Jan 28, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Separation Failure” (1 report).

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.

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.

• MalfunctionJan 28, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 2MM X 4CM HELIPAQ 18 CERECYTE COIL (CHE18020430 / L12647) DID NOT DETACH. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT STILL ATTACHED TO THE DELIVERY SYSTEM. THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED. IT WAS REPORTED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE LOW BATTERY LIGHT AND THE FAULT LIGHT WERE NOT SEEN DURING THE CASE. THE GREEN SYSTEM READY LIGHT ILLUMINATED WHEN THE POWER BUTTON WAS PRESSED; THE AUDIBLE SIGNAL BEEP WAS HEARD WHEN THE DETACHMENT CYCLE WAS INITIATED. ALL THE CONNECTIONS WERE REPORTED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. A NEW CABLE WAS REPLACED BEFORE ANOTHER COIL WAS REPLACED BUT THE 2MM X 4CM HELIPAQ 18 CERECYTE COIL STILL WOULD NOT DETACH. ANOTHER COIL WAS USED, AND EVERYTHING WENT WELL. THE CONTROL CABLE AND THE DETACHMENT CONTROL BOX WAS USED TO DETACH SUBSEQUENT COILS. THE REPORTED ISSUE DID NOT RESULT IN ANY SIGNIFICANT PROCEDURAL DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9638487 ↗