DELTAMAXX CERECYTE CDX181040-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10878528008610), received between Jul 11, 2017 and Jul 18, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• MalfunctionJul 18, 2017Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE RESISTANCE WAS EXPERIENCED WITH THE MICROCATHETER WHEN USING A DELTAMAXX COIL (CDX18104030/C36983), THE COIL ALSO UNRAVELED DURING THE PROCEDURE. THE PROCEDURE WAS DURAL-ARTERIO VENOUS FISTULAE (TVE) COIL EMBOLIZATION OF AN ANEURYSM AT THE TRANSVERSE SIGMOID SINUS. A MICRO CATHETER WAS APPROACHED TO THE SINUS FROM THE JUGULAR VEIN. WHEN DELTAMAXX COIL (COMPLAINT PRODUCT) WAS INSERTED, THERE WAS STRONG RESISTANCE FELT, SO IT WAS WITHDRAWN INTO THE MICRO CATHETER HOWEVER THERE WAS STILL RESISTANCE FELT. THE COIL HAD UNRAVELED. THE COIL AND THE MICRO CATHETER WERE REMOVED SUCCESSFULLY. THE COIL WAS REPLACED WITH COMPETITIVE ONE. MORE THAN HALF OF THE DELTAMAXX COIL WAS PLACED IN THE BLOOD VESSEL, SO THE COIL UNRAVELING OCCURRED EITHER INSIDE THE MICRO CATHETER OR INSIDE THE BLOOD VESSEL. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN ACCESSING THE TARGET SITE. 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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6722703 ↗
• InjuryJul 11, 2017Physical Resistance; Device Operates Differently Than Expected; Physical Resistance; Device Operates Differently Than Expected

  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 6703580 ↗