DELTAMAXX CERECYTE CDX180935-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10878528008603), received between Jun 15, 2017 and Jun 15, 2017 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING THE PROCEDURE A DELTAMAXX CERECYTE 18SYS (CDX18093530/C34622) COIL FAILED TO DETACH. THE PROCEDURE WAS THE ENDOVASCULAR ANEURYSM REPAIR OF AN ANEURYSM AT THE INTERNAL ILIAC ARTERY. COILS (PRESIDIO18X12MM, DELTAMAXX 10MM, DELTAMAXX 9MM) WERE INSERTED IN ORDER, AFTER WHICH THE DELTAMAXX (COMPLAINT PRODUCT ) WAS INSERTED AS THE FOURTH COIL AND THE COIL WAS PLACED. HOWEVER, THE COIL COULD NOT BE DETACHED. THEREFORE, THE COIL WAS REPLACED WITH ANOTHER ONE (DIFFERENT LOT #, SAME SIZE). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY OR COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND A CONSTANT FLUSH WAS MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6643243 ↗