DELTAMAXX CERECYTE CDX182460-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10878528008757), received between Nov 30, 2016 and Dec 28, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2020Device Difficult to Setup or Prepare; Positioning Problem; Device Difficult to Setup or Prepare; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 24MM X 60CM DELTAMAXX CERECYTE® COIL (CDX18246030 / C38840) WAS THE FIRST COIL CHOSEN FOR THE PROCEDURE. THE PHYSICIAN DECIDED TO RETRACT THE COIL FOR REDEPLOYMENT, (THE SECOND ATTEMPT TO BETTER POSITION THE COIL). DURING THE RESHEATHING, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED ANOTHER 24MM X 60CM DELTAMAXX CERECYTE® COIL AS REPLACEMENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED STRETCHED AND KINKED. BASED ON THE PRODUCT ANALYSIS 12/28/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11083620 ↗
• MalfunctionMay 10, 2017Difficult To Position; Unraveled Material; Difficult To Position; Unraveled Material

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A LEFT INTERNAL ILIAC ARTERY ANEURYSM, A DELTAMAXX (CDX18246030/(B)(4)) WAS DIFFICULT TO PLACE AND UNRAVELED. THE DELTAMAXX WAS THE FIRST COIL USED, BUT THE COIL WAS DIFFICULT TO PLACE, WAS MOVED IN AND OUT OF THE ANEURYSM SEVERAL TIMES, AND UNRAVELED. THE COIL WAS REMOVED FROM THE PATIENT¿S BODY WITH THE PROWLER SELECT PLUS MICROCATHETER, AND THE COIL WAS REPLACED WITH ANOTHER ONE (PRESIDIO). 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 AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. THE PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6557009 ↗
• MalfunctionNov 30, 2016Positioning Failure; Positioning Failure

  IT WAS REPORTED BY THE CONTACT AT THE USER FACILITY THAT A DELTAMAXX CERECYTE COIL (CDX18246030/C31667) FAILED TO DETACH DURING A COIL EMBOLIZATION PROCEDURE. THE COMPLAINT COIL WAS WITHDRAWN AND IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM UPON REMOVAL; NO STRETCHING WAS NOTED ON THE COIL UPON REMOVAL. A PRE-DEPLOYMENT ELECTRICAL CHECK PERFORMED. THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE AND THE DETACHMENT LIGHT DID NOT ILLUMINATE DURING THE DETACHMENT CYCLE. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THE SAME CONNECTING CABLE AND DCB WERE USED SUCCESSFULLY. THERE WAS NO REPORT ON PATIENT INJURY. THERE WERE NO INTRA OR POST PROCEDURAL COMPLICATIONS OR DELAYS RELATED TO DEVICE OR REPORTED EVENT. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6134716 ↗