DELTAMAXX CERECYTE CDX181650-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10878528008672), received between Nov 3, 2016 and Apr 3, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2018Positioning Failure; Positioning Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN USED TWO OF THE DELTAMAXX CERECYTE 18SYS 16 X 50 COILS (CDX1815030), THE FIRST COIL (CDX1815030 / C29347) FAILED TO DETACH AS EXPECTED DESPITE THE USE OF TWO DIFFERENT DETACHMENT SYSTEMS. THE COIL WAS RETRIEVED AND REMOVED FROM THE PATIENT. THE SECOND COIL WAS USED AND IT DETACHED AS EXPECTED USING ONE OF THE DETACHMENT SYSTEMS. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION, NO SIGNIFICANT DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7393479 ↗
• MalfunctionJul 28, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A SUBCLAVIAN ARTERY ANEURYSM FOR TYPE 1A ENDOLEAK, A DELTAMAXX COIL (CDX18165030/ S00037) FAILED TO DETACH USING AN ENPOWER CONTROL CABLE (ECB00018200/ S13060). A 5FR MSKIT WAS INSERTED INTO THE VESSEL AND IT WAS TAKEN TO THE STENT GRAFT AT DISTAL END. FROM THAT ROUTE, THE MICROCATHETER WAS INSERTED INTO THE END LEAK PORTION THEN THE EMBOLIZATION WAS STARTED. AFTER 10 COILS (DELTAMAXX) WERE PLACED IN THE LESION, THE COMPLAINT DELTAMAXX WAS OPENED. ALL 10 COILS HAD DETACHED WITH THE SAME ENPOWER CONTROL CABLE. AFTER PRE-DEPLOYMENT ELECTRICAL CHECK, THE MICROCATHETER WAS INSERTED TOWARD THE DETACHMENT POINT. THE COMPLAINT COIL WAS CONNECTED TO THE COMPLAINT CABLE FOR DETACHMENT, BUT THE POWER LAMP DID NOT ILLUMINATE. THE DELIVERY WIRE WAS MOVED A LITTLE BACK AND FORTH, THEN THE POWER LAMP ILLUMINATED. THEN THE PHYSICIAN PRESSED THE DETACHMENT BUTTON, BUT IT COULD NOT BE DETACHED. HE MOVED THE DELIVERY COIL A LITTLE REPEATEDLY, BUT THE ISSUE CONTINUED. THEREFORE, THE ENPOWER CONTROL CABLE WAS REPLACED, BUT THE LAMP WAS ILLUMINATED INTERMITTENTLY. ENPOWER CONTROL BOX WAS REPLACED, BUT THE ISSUE CONTINUED. FINALLY, TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6749818 ↗
• MalfunctionApr 4, 2017Material Deformation; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE A DELTAMAXX COIL GOT DAMAGED IN AN ATTEMPT TO RE-SHEATH THE COIL. THE PROCEDURE WAS PRE-TEVAR COIL EMBOLIZATION FOR DISSOCIATION CAVITY NEAR THE UPPER PART OF THE RENAL ARTERY. THE PATIENT¿S VESSEL WAS HEAVILY TORTUROUS AND HEAVILY CALCIFIED. FIVE (5) COILS (PRESIDIO) WERE USED WITH DOUBLE CATHETER AND THE DELTAMAXX (COMPLAINT PRODUCT) WAS USED AFTER ANCHOR. HOWEVER, THE DELTAMAXX COIL WAS TOO LONG FOR THE LESION AND ALSO THE MICRO CATHETER CAME OFF, SO IT WAS ATTEMPTED TO RETRIEVE THE COIL TO CORRECT THE POSITION OF THE CATHETER. THE COIL GOT DAMAGED WHEN RE-SHEATHING WAS ATTEMPTED, IT IS UNKNOWN WHICH PART OF THE COIL WAS DAMAGED. THE COIL WAS REPLACED WITH ANOTHER DELTAMAXX COIL (LOT UNKNOWN). THE MICRO CATHETER WAS REINSERTED. AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WERE NO DAMAGES REPORTED ON THE COMPLAINT COIL PRIOR TO USE. THERE WAS ALSO NO PATIENT INJURY / 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 TIMES. NO VISIBLE DEFECT/DAMAGE WAS NOTE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6456751 ↗
• MalfunctionNov 3, 2016Positioning Failure; Stretched; Positioning Failure; Stretched

  REPORTED BY A CONTACT AT THE USER FACILITY THAT DURING A COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM AT THE SPLENIC ARTERY, A DELTAMAXX CERECYTE 18SYS 16X50 COIL (CDX18165030), LOT NUMBER C31359, FAILED TO DETACH. IT WAS USED ON A FEMALE PATIENT, AGE UNKNOWN. THE PATIENT'S VESSEL WAS MILDLY TORTUOUS AND WAS NOT CALCIFIED. THE CATHETER (SELECON MP) WAS USED INSTEAD OF GUIDING CATHETER AND IT WAS APPROACHED TO CELIAC TRUNK. THE MICRO CATHETER WAS APPROACHED TO THE SPLENIC ARTERY AND EMBOLIZATION WAS STARTED. AFTER FOUR COILS WERE USED, THE COMPLAINT COIL WAS USED. THE PHYSICIAN REPORTED THAT EVEN THOUGH THE DETACHMENT LIGHT WAS ILLUMINATED, THE COIL DID NOT DETACH. THEY REMOVED THE COIL AND REINSERTED IT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL AGAIN, BUT WAS UNSUCCESSFUL. THE PHYSICIAN TRIED TO DETACH THE COIL USING FORCE. THEY ATTEMPTED TO TROUBLESHOOT FOUR TIMES. THE COIL UNRAVELED APPROXIMATELY 10CM DURING RETRIEVAL. IT WAS WITHDRAWN SLOWLY AND WAS FINALLY WITHDRAWN WITH THE MICRO CATHETER. THE COIL WAS RETRIEVED COMPLETELY AND BOTH THE COIL AND MICRO CATHETER WERE REPLACED WITH ANOTHER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES. HOWEVER, DUE TO THE EVENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6075285 ↗