DELTAMAXX CERECYTE CDX180520-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10878528008566), received between Sep 13, 2016 and Dec 23, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Kinked” (2 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.

• InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE AAA STUDY, AN (B)(6) FEMALE PATIENT WITH A PAST MEDICAL HISTORY OF HYPERTENSION, DIABETES, CEREBROVASCULAR DISEASE, AND DYSLIPIDEMIA UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF AN INFRARENAL 46MM ABDOMINAL AORTIC ANEURYSM (AAA) AND EXPERIENCED TYPE II TARGET VESSEL ENDOLEAKS AT DAYS 81 AND 179. THE PROCEDURE WAS AN INITIAL ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR (EVAR). THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. STENT GRAFT USED WAS A GORE EXCLUDER LEG. A TOTAL OF TWO SPECTRA (CERENOVUS) COILS WERE IMPLANTED AT THE INFERIOR MESENTERIC ARTERY (IMA): ONE 4MM X 15CM DELTAMAXX (CDX18041530 / LOT# UNKNOWN) AND ONE 5MM X 20CM DELTAMAXX (CDX18052030 / LOT# UNKNOWN). FLUOROSCOPY TIME WAS 157 MINUTES. THE COIL EMBOLIZATION WAS DEEMED SUCCESSFUL. THE PATIENT WAS HOSPITALIZED TEN DAYS.

  Patient problems: Aneurysm

  MAUDE report 13080216 ↗
• MalfunctionJul 7, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING THE PROCEDURE A DELTAMAXX COIL (CDX18052030/S11694) FAILED TO DETACH. THE PROCEDURE WAS PRE-STENT GRAFTING COIL EMBOLIZATION OF AN ABDOMINAL AORTIC ANEURYSM AT THE LUMBAR. THE PATIENT WAS A (B)(6)MALE WHOSE VESSEL WAS MODERATELY TORTUROUS AND MILDLY CALCIFIED. THE GUIDING CATHETER AND THE MICRO CATHETER WERE INSERTED FROM THE RIGHT FEMORAL ARTERY AND WERE APPROACHED TO THE LUMBER ARTERY #3. FIRST COIL (DELTAMAXX 6MM) WAS INSERTED AND WAS DETACHED. AFTER WHICH THE COMPLAINT DELTAMAXX COIL WAS INSERTED AND THE DETACHMENT BUTTON WAS PRESSED BUT IT COULD NOT BE DETACHED. BOX WAS REBOOTED AND THE CABLE WAS RECONNECTED BUT THE ISSUE CONTINUED ALTHOUGH THE PHYSICIAN ATTEMPTED TO DETACH THE COIL ABOUT 4 TIMES. THE COIL WAS REPLACED WITH ANOTHER ONE (SAME SIZE). THE COIL EMBOLIZATION WAS PERFORMED AT LUMBAR ARTERY AND IIA SIDE BRANCHES AND THE PROCEDURE WAS COMPLETED WITH EIGHT MICRUS COILS. 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 6694595 ↗
• MalfunctionMay 18, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE A DELTAMAXX COIL ((B)(4)) UNRAVELED AND TWO TRUFILL DCS SYRINGES II ((B)(4)) WERE UNABLE TO CREATE PRESSURE. THE PROCEDURE WAS THE COIL EMBOLIZATION OF AN ANEURYSM FOR ARTERIOVENOUS FISTULA AT THE LEFT PULMONARY ARTERIOVENOUS. THE PATIENT¿S VESSEL WAS HEAVILY TORTUROUS AND MILDLY CALCIFIED. THE DELTAMAXX COIL (COMPLAINT PRODUCT1) WAS THE FIRST COIL USED AS AN ANCHOR, THE COIL UNRAVELED AND THE COIL CAME OFF OUTSIDE THE BODY DURING REMOVAL OF THE COIL. THE COIL WAS REPLACED WITH ANOTHER ONE (SAME SIZE) AND THE PROCEDURE WAS CONTINUED. WHEN PURGING, THE PRESSURE OF GALAXY COIL DID NOT INCREASE WITH THE TRUFILL SYRINGE (COMPLAIN PRODUCT2). THE SYRINGE WAS REPLACED WITH A NEW TRUFILL DCS SYRINGE II (COMPLAINT PRODUCT3) BUT THE SAME ISSUE OCCURRED. THE SYRINGE 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 AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. THE PRODUCTS WILL BE RETURNED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6574897 ↗
• MalfunctionApr 4, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE, UNRAVELING AND RESISTANCE WAS EXPERIENCED WHEN USING A DELTAMAXX18 SYS 5X20 COIL. THE PROCEDURE WAS COIL EMBOLIZATION FOR BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION AT THE GASTRIC VEIN. THE DELTAMAXX COIL (COMPLAINT PRODUCT) WAS USED AFTER SEVERAL COILS WERE USED BUT IT GOT STUCK IN THE MICRO CATHETER, FURTHERMORE, THE COIL WAS UNRAVELED. THE COIL WAS REMOVED. 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 A CONSTANT FLUSH WAS MAINTAINED AT ALL TIMES. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO (AND AFTER) 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 6457011 ↗
• MalfunctionDec 22, 2016Positioning Failure; Kinked; Positioning Failure; Kinked

  THE CONTACT FROM THE FACILITY REPORTED THAT DURING COIL EMBOLIZATION OF AN ANEURYSM AT THE HEPATIC ARTERY, THE DELIVERY WIRE OF THE DELTAMAXX COIL (CDX180520-30/ C36979) WAS KINKED AND THE COIL DID NOT DETACH. THE PATIENT¿S INFORMATION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WERE UNKNOWN. A DELIVERY WIRE OF THE DELTAMAXX WAS INSERTED INTO THE PATIENT AND IT GOT KINKED. THE DELIVERY WIRE WAS HELD BY A FORCEPS TO ADVANCE. HOWEVER THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE WITH THE COMPLAINT COIL AND NO SOUND WAS HEARD WHEN THE DEPLOYMENT BUTTON WAS PRESSED. THEREFORE IT WAS REPLACED WITH A NEW MICRO COIL. IN THIS PROCEDURE, EIGHT MICRO COILS WERE IMPLANTED IN TOTAL. 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 TIMES. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO AND AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICRO CATHETER. THE PRODUCT IS NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6199854 ↗
• MalfunctionSep 13, 2016Kinked; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A DELTAMAXX (CDX18052030/C40537) PROTRUDED THROUGH THE INTRODUCER 15CM FROM THE DISTAL END AND COIL DAMAGE WAS FOUND DURING PRODUCT ANALYSIS, AND THERE WAS RESISTANCE BETWEEN THE CASHMERE (CRC14071730/C14361) AND THE NON-CODMAN MICROCATHETER. THE COMPLAINT DELTAMAXX WAS PLACED AT THE SPLENIC ARTERY ANEURYSM, AND RETRIEVED WITHOUT DETACHMENT. IN ORDER TO REUSE THE SAME DELTAMAXX, THE PHYSICIAN PUT THE INTRODUCER TO Y CONNECTOR AND INDUCED THE DELIVERY WIRE. HE THEN FOUND THAT THE COIL STUCK OUT FROM 15CM FROM DISTAL END OF INTRODUCER. HE DECIDED TO USE A DIFFERENT COIL AS THE DELTAMAXX WAS NOT ABLE TO BE INDUCED. HE THEN TRIED TO INSERT THE COMPLAINT CASHMERE BY INSERTING INTRODUCER TO Y CONNECTOR OF THE NON-CODMAN MICROCATHETER; HOWEVER, HE FELT RESISTANCE AROUND 50CM AWAY FROM THE PROXIMAL END. THE RESISTANCE BECAME STRONGER WHILE HE CONTINUED INSERTING, AND HE RETRIEVED THE COIL AND USED A NEW COIL. 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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5946510 ↗