HELIPAQ CERECYTE CHE180730-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528000778), received between Dec 16, 2016 and Oct 9, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A HELI 18 CERE COIL (CHE18073030/C40080) WOULD NOT DETACH DURING A COILING PROCEDURE. THEY TRIED EVERYTHING. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6930389 ↗
• MalfunctionDec 16, 2016Premature Activation; Premature Activation

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT DURING AN INTERVENTION THE SURGEON RECOGNIZED THE WHITE SHEATH OF A HELIPAQ CERE 7MM X 30 CM COIL (CHE18073030/C14002)TO BE DEFECTIVE, IT WAS TORN. THE COIL INTRODUCER SHEATH WAS FOUND TO BE SPLIT OPEN. THE PRODUCT ISSUE WAS DISCOVERED BEFORE IT WAS USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SAME LIKE PRODUCT. NO SIGNIFICANT DELAY OR PATIENT HARM REPORTED. THERE WERE NO INTRA OR POST PROCEDURAL COMPLICATIONS RELATED TO DEVICE OR REPORTED EVENT. THERE WERE NO OTHER ISSUES REPORTED WITH THE PRODUCT. IT WAS INITIALLY REPORTED THAT THE COMPLAINT DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6181283 ↗