HELIPAQ CERECYTE CHE100930-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878528000600), received between May 11, 2017 and May 11, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Premature Activation” (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.

• MalfunctionMay 11, 2017Premature Activation; Premature Activation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ANEURYSM COIL EMBOLIZATION PROCEDURE, A HELIPAQ COIL (CHE10093030/ S10856) WAS NOT SEEN ON THE WIRE FROM THE BEGINNING OF THE PROCESS. IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS NO COIL. THE EVENT WAS IDENTIFIED PRIOR TO USE ON THE PATIENT DURING DEVICE PREPARATION. THE COIL WAS ALSO NOT SEEN IN THE PACKAGING. UPON ANALYSIS OF THE RETURNED PRODUCT, IT WAS FOUND THAT THE MECHANICALLY DETACHED COIL WAS IN THE INTRODUCER SHEATH AND THE DPU AND INTRODUCER SHEATH WERE SEPARATED. ANOTHER PRODUCT OF THE SAME BRAND WAS USED, BUT OF SMALLER LENGTH. THE PRODUCT WAS STORED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE PACKAGING DID NOT APPEAR DAMAGED AND THE DEVICE WAS PACKAGED AS EXPECTED. THE EVENT DID NOT RESULT IN A PROCEDURE DELAY AND THE DEVICE WAS NO USED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6560708 ↗