DELTAMAXX CERECYTE CDX180625-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10878528008573), received between Dec 6, 2016 and Jul 11, 2017 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Stretched” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2017Stretched; Device Operates Differently Than Expected; Difficult to Advance; Stretched; Device Operates Differently Than Expected; Difficult to Advance

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT TWO DELTAMAXX COILS (CDX181040-30/S10881 & CDX180625-30/S12652) WERE USED DURING A COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM FOR A TYPE II ENDOLEAK AT THE LUMBAR IIA WHERE RESISTANCE WAS EXPERIENCED BETWEEN BOTH DELTAMAXX COILS AND THE MICROCATHETER; HOWEVER, THE FIRST DELTAMAXX COIL (CDX181040-30/S10881) COULD NOT BE DELIVERED AT ALL AND THE SECOND DELTAMAXX COIL (CDX180625-30/S12652) GOT STUCK AND BECAME UNRAVELED. AN IPSILATERAL APPROACH WAS MADE FROM THE IIA AND A GUIDING CATHETER WAS ADVANCED TO THE ILEOSTOMY ARTERY. THE ILEOCOLIC ARTERY WAS CONNECTED TO THE ABDOMINAL AORTIC ANEURYSM AND THE DECISION WAS MADE TO RETURN FROM THE TIP. COIL EMBOLIZATION WAS CONDUCTED WITH GALAXY, AXURCX, TERUMO CLINICAL SUPPLY, AND DELTAMAXX. DELTAMAXX COMPLAINT COIL 1 (CDX181040-30/S10881) WAS USED IN THE MIDDLE OF THE PROCEDURE, BUT STRONG RESISTANCE WAS FELT FROM THE TIP OF THE CATHETER TO THE MIDDLE. THE COIL COULD NOT BE DELIVERED AT ALL. DELTAMAXX COMPLAINT COIL 2 (CDX180625-30/S12652) WAS USED AT THE END OF THE PROCEDURE AND RESISTANCE WAS FELT. THE COIL WAS IN AND OUT, REPEATEDLY, AND AN ATTEMPT WAS MADE TO RE-SHEATH THE COIL. THE COIL GO

  Patient problems: No Code Available

  MAUDE report 6703574 ↗
• InjuryMay 9, 2017Material Separation; Stretched; Material Separation; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE RESISTANCE WAS EXPERIENCED WITH THE MICROCATHETER WHEN USING A DELTAMAXX COIL (CDX18062530/S12585). THE COIL HAD ALSO SEPARATED AND UNRAVELING, AND PART OF THE COIL REMAINS IN THE PATIENT. THE PROCEDURE WAS DELAYED BY 100 MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COIL EMBOLIZATION OF HEPATIC ARTERY CHEMOEMBOLIZATION/VARICOSE SHUNT AT THE GASTRIC ARTERY. THE PATIENT¿S VESSEL WAS MODERATELY TORTUROUS AND NOT CALCIFIED. AN APPROACH WAS MADE FROM RIGHT FEMORAL ARTERY BY HEPATIC ARTERIAL CHEMOEMBOLIZATION, THE GUIDING CATHETER AND THE MICRO CATHETER WERE ACCESSED TO THE TARGET LESION AS A UNIT. AFTER COMPLETION OF INTUBATION THERAPY, A VARICOSE SHUNT CONNECTED FROM THE GASTRIC ARTERY WAS CONFIRMED WITH A CONTRAST AND COIL EMBOLIZATION OF THE TARGET GASTRIC ARTERY WAS PERFORMED. AFTER ACCESSING WITH THE ABOVE SYSTEM, THE FIRST COIL A DELTAMAXX (COMPLAINT PRODUCT) WAS SELECTED AND PREPARATION WAS PERFORMED ACCORDING TO IFU AND THE COIL WAS INSERTED BY THE PHYSICIAN (2ND). HOWEVER, WHEN TWO-THIRDS OF THE COIL WAS INSERTED INTO THE MICRO CATHETER RESISTANCE WAS EXPERIENCED. IT WAS DIFFICULT TO INSERT THE COIL; THE PRO

  Patient problems: No Code Available

  MAUDE report 6553599 ↗
• MalfunctionMar 31, 2017Stretched; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING THE PROCEDURE AN ORBIT GALAXY COMPLEX FILL COIL FAILED TO RESHEATH AND RESISTANCE WAS EXPERIENCED WHEN USING A DELTAMAXX COIL WHICH ALSO UNRAVELED. THE PROCEDURE WAS THE GASTRODUODENAL ARTERY ANEURYSM COIL EMBOLIZATION. THE PATIENT WAS A (B)(6) MALE WHOSE VESSEL WAS MODERATELY TORTUROUS AND NOT CALCIFIED. THE OG CMPLX FILL (COMPLAINT PRODUCT1) WAS ATTEMPTED TO USE FOR EMBOLIZATION OF THE GDA-AN OUTFLOW ARTERY. HOWEVER, IT WAS A SMALLER SIZE FOR THE LESION SO THE PHYSICIAN TRIED TO RE-SHEATH THE COIL. BUT THE ORANGE-COLORED ZIPPER DID NOT SLIDE AND THE COIL WAS UNABLE TO BE RE-SHEATHED. THE COIL WAS REPLACED WITH ANOTHER ONE. A DELTAMAXX (COMPLAINT PRODUCT2) COIL WAS INSERTED INTO THE MICRO CATHETER BUT THERE WAS STRONG RESISTANCE FELT AT THE MIDDLE PORTION OF THE CATHETER, SO THE COIL WAS WITHDRAWN, IT WAS FOUND THAT THE COIL UNRAVELED. THE COIL WAS REPLACED WITH ANOTHER ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. 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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6449073 ↗
• MalfunctionMar 7, 2017Fracture; Fracture

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT DURING THE PROCEDURE RESISTANCE WAS EXPERIENCED WHEN USING A DELTAMAXX COIL AND THE COIL SEPARATED DURING USE. THE PROCEDURE WAS PARTIAL SPLENIC ARTERY EMBOLIZATION AND THE TARGET LESION WAS AT THE BRANCHING OF SPLENIC ARTERY. THE PATIENT¿S VESSEL WAS MILDLY TORTUROUS. THE PHYSICIAN PUNCTURED FROM RIGHT FEMORAL ARTERY; THE GUIDING CATHETER, THE MICRO CATHETER AND THE GUIDE WIRE WERE INSERTED. THE MICRO CATHETER WAS APPROACHED TO THE SPLENIC ARTERY AND THE SELECT TARGET BLOOD VESSEL UNDER CONTRAST ENHANCED IMAGES. THE COIL EMBOLIZATION WAS PERFORMED AT THE FIRST VESSEL. THE DELTAMAXX (COMPLAINT PRODUCT) WAS SELECTED AS THE FIRST COIL. THE PHYSICIAN PREPARED THE COIL AND AN ASSISTANT INSERTED THE COIL. THE COIL WINDING WAS CONDUCTED SEVERAL TIMES IN THE VESSEL. HOWEVER THERE A LITTLE RESISTANCE WAS FELT WHEN THE DELIVERY WIRE WAS WITHDRAWN. THE COIL WAS WITHDRAWN CONTINUOUSLY, THEN CONNECTION PART BETWEEN THE COIL AND DELIVERY WIRE SEPARATED. APPROXIMATELY ONE QUARTER OF THE COIL BODY REMAINED IN THE BLOOD VESSEL AND THE OTHER REMAINED IN THE MICRO CATHETER. THE MICRO CATHETER WAS REMOVED FROM THE PATIENT¿S BODY AND COIL WAS RETRIEV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6383458 ↗
• MalfunctionDec 20, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION PROCEDURE IT WAS REPORTED THAT A PRESIDIO 18 ((B)(4)) COIL WAS FOUND TO BE EXPOSED FROM ITS SHEATH AND A DELTAMAXX COIL ((B)(4)) FAILED TO DETACH. THE PROCEDURE WAS COIL EMBOLIZATION OF AN ARTERIOVENOUS MALFORMATION AT THE LUNG IN A (B)(6) FEMALE PATIENT WHOSE VESSELS WERE NOT TORTUROUS AND NOT CALCIFIED. WHEN THE PRESIDIO18 COIL WAS TAKEN OUT FROM ITS POUCH, THE MICRO COIL WAS PREMATURELY EXPOSED APPROXIMATELY 10 CM FROM THE DISTAL TIP OF THE SHEATH. THEREFORE THE PRESIDIO18 WAS REPLACED WITH A NEW PRODUCT. THEN THE DELTAMAXX COIL WAS INSERTED INTO THE MICRO CATHETER AND IT WAS ATTEMPTED TO DETACH THE MICRO COIL; HOWEVER THE COIL COULD NOT BE DETACHED. THEREFORE THE DELTAMAXX WAS REMOVED FROM THE PATIENT. IT WAS UNKNOWN HOW THE PROCEDURE COMPLETED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO AND AFTER THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6189096 ↗
• MalfunctionDec 6, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN UNKNOWN TARGET VESSEL, THE DELTAMAXX COIL (CDX18062530/ C32741) COULD NOT BE DETACHED. THEY WITHDREW THE COIL COMPLETELY, WITHOUT ADDITIONAL INTERVENTION, AND USED A NEW COIL TO COMPLETE THE PROCEDURE. THERE HAD BEEN NO RESISTANCE BETWEEN THE DELTAMAXX AND THE UNSPECIFIED MICROCATHETER. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. AN ENPOWER DCB AND ENPOWER CABLE WERE USED FOR THE PROCEDURE AND WERE USED TO COMPLETE THE PROCEDURE. A PRE-DEPLOYMENT CHECK HAD BEEN PERFORMED. UPON PRESSING THE POWER BUTTON, ALL LIGHTS DID NOT ILLUMINATE. THE GREEN SYSTEM READY LIGHT ILLUMINATED. DURING DETACHMENT CYCLE, THE DETACHMENT LIGHT DID NOT ILLUMINATE AND THE AUDIBLE SIGNAL DID NOT BEEP. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THERE WAS NO REPORT OF PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6147158 ↗