HELIPAQ CERECYTE CHE182030-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878528000877), received between Nov 22, 2016 and Nov 22, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionNov 22, 2016Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE HELIPAQ COIL 20 X 30 (CHE18203020/C39307) WAS IMPEDED IN THE COIL INTRODUCER AND THE COIL INTRODUCER WAS DAMAGED. AS REPORTED BY A HEALTH CARE PROFESSIONAL COIL DID NOT NAVIGATE THROUGH THE MICROCATHETER (COMPETITOR¿S DEVICE) AND ALSO THE GREEN ZIPPER PIECE BROKE IN HALF AS THE COIL WAS BEING LOADED INTO MICROCATHETER. COIL WAS REMOVED AND A SECOND HELIPAQ 20 X 30 WAS PLACED WITHOUT ANY ISSUES USING THE SAME MICROCATHETER. THERE WERE NO DAMAGES NOTED ON THE MICROCATHETER PRIOR TO USE OR UPON REMOVAL. PATIENT WAS NOT INJURED AND THE REPORTED EVENT CAUSED A 10 MINUTE DELAY IN THE CASE. THE PATIENT¿S PRESENT CONDITION IS GOOD. IT WAS REPORTED THAT THE PATIENT HAD LOW VESSEL TORTUOSITY AND HAD NORMAL TARGET LESION CHARACTERISTICS; TARGET VESSEL WAS THE HYPOGASTRIC ARTERY. FIVE (5) ADDITIONAL HELIPAQ COILS WERE IMPLANTED WITHOUT ISSUE. IT WAS INITIALLY REPORTED THAT THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6121857 ↗