DELTAMAXX CERECYTE CDX180835-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10878528008597), received between Aug 30, 2016 and Aug 14, 2019 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 8X35 DELTAMAXX CERECYTE 18SYS (CDX18083530, S13453) WAS BEING USED FOR FILLING, HOWEVER, THE PHYSICIAN DIDN'T LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO PULL IT OUT. DURING RESHEATHING THE COIL, THE INTRODUCER WAS DEFECTED NOT TO BE UNZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8893077 ↗
• MalfunctionJul 18, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE RESISTANCE WAS EXPERIENCED WHEN USING A DELTAMAXX COIL (CDX18083530/S10381) WHICH HAD ALSO UNRAVELED. THE PROCEDURE WAS COIL EMBOLIZATION OF AN ANEURYSM AT THE ABDOMINAL STENT GRAFT INTERPOLATION AT THE RIGHT INTERNAL ILIAC ARTERY. THE PATIENT WAS (B)(6) MALE WHOSE VESSEL WAS MILDLY TORTUROUS AND NOT CALCIFIED. THE DELTAMAXX COIL (COMPLAINT PRODUCT) WAS INSERTED INTO THE MICRO CATHETER HOWEVER RESISTANCE WAS FELT. THE COIL WAS REMOVED FROM THE PATIENT AND WAS FOUND TO BE UNRAVELED. THE COIL WAS REPLACED WITH ANOTHER ONE (DIFFERENT LOT#). 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 WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT WILL BE RETURNED FOR I

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6723313 ↗
• MalfunctionJul 10, 2017Knotted; Knotted

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING PREPARATION A DELTAMAXX COIL (CDX18083530/C41169) WAS EXPOSED FROM THE MIDDLE PORTION WHEN THE INTRODUCER SHEATH WAS UNZIPPED. THE COIL WAS REPORTEDLY NOT DAMAGED. THE PROCEDURE WAS FOR AN ABDOMINAL EMERGENCY CASE. THE PHYSICIAN COMMENTED THAT THE COIL WAS NOT HANDLED CARELESSLY OR WITH FORCE. 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. THE PRODUCT WILL BE RETURNED FOR INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE. UPON RECEIVING THE DEVICE, THE PROXIMAL PORTION OF THE COIL WAS ENTANGLED. IT IS UNKNOWN WHEN THIS ISSUE OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6697732 ↗
• MalfunctionJun 21, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A DELTAMAXX COIL (CDX180835-30/C39755), A PROWLER SELECT PLUS MICROCATHETER (606-S255FX/17647636) AND AN ENPOWER CONTROL CABLE(ECB000182-00/S11830) WERE USED DURING A COIL EMBOLIZATION PROCEDURE OF A RUPTURED THORACIC ANEURYSM AT THE LEFT SUBCLAVIAN ARTERY WHERE THE COIL COULD NOT BE DETACHED AND WAS FOUND TO HAVE UNRAVELED AND ENTANGLED WITH THE TIP OF THE MICROCATHETER. AFTER ANCHORING WITH A PRESIDIO COIL, THE DELTAMAXX COIL (COMPLAINT PRODUCT 1), USED AS THE 3RD COIL, COULD NOT BE DETACHED. AN ATTEMPT WAS MADE TO REMOVE THE COIL BUT IT WAS UNRAVELED. ALL SYSTEMS WERE REMOVED FROM THE PATIENT AS THE COIL WAS ENTANGLED IN THE TIP OF THE PROWLER SELECT PLUS MICROCATHETER (COMPLAINT PRODUCT 2); THE COIL WAS REMOVED COMPLETELY. THERE WAS CONCERN THAT THE MICROCATHETER WAS BROKEN SO THE ENPOWER CONTROL CABLE (COMPLAINT PRODUCT 3) WAS ALSO REPLACED. IT IS POSSIBLE THAT THE CABLE GOT DIRTY DURING THAT TIME. THE COIL WAS REPLACED WITH ANOTHER OF THE SAME SIZE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY 4 COILS WITHOUT FURTHER ISSUES OR DELAY. REPORTEDLY, THE PATIENT WAS A (B)(6) MALE, WHOSE VESSEL WAS HEAVILY TORTUOUS AND HEAVILY CAL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6658448 ↗
• MalfunctionJun 6, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, FROM THE BEGINNING, RESISTANCE WAS FELT BETWEEN THE 0.014 PROXES GUIDEWIRE AND THE PROWLER SELECT PLUS (606S155FX/ 17474090), SO IT WAS REPLACED WITH ANOTHER MICROCATHETER. A DELTAMAXX (CDX18041530/S10982) DID NOT FIT THE LESION, SO THE PHYSICIAN TRIED TO RE-SHEATH THE COIL; HOWEVER, THE PRE-SCORE PEEL WAS BROKEN. EXCESSIVE FORCE HAD NOT BEEN APPLIED. THE DEVICE WAS USED AND PREPPED AS PER THE IFU. THEN A DELTAMAXX (CDX18083530/ S10592) WAS ATTEMPTED TO BE DETACHED WITH AN ENPOWER CONTROL CABLE (ECB00018200/S13060), BUT THE COIL COULD NOT DETACH. FURTHERMORE, THE SYSTEM READY LIGHT HAD GONE OFF AT THE FOURTH DETACHMENT ATTEMPT; THEREFORE, THE CABLE WAS REPLACED WITH ANOTHER ONE. THE LIGHT REMAINED OFF, SO THE COIL WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES USING THE REPLACEMENT CABLE. HOWEVER, DUE TO THE EVENT, IT WAS DELAYED FOR 10 MINUTES. 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. NO VISIBLE DEFECT/DAMAGE WAS NOT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6613998 ↗
• MalfunctionFeb 9, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN ANEURYSM AT THE SPLENIC ARTERY A DELTAMAXX COIL FAILED TO DETACH. THE PATIENT¿S VESSELS WERE NOT TORTUROUS AND NOT CALCIFIED. THE PHYSICIAN PRESSED THE DETACHMENT BUTTON OF THE ENPOWER CABLE BUT THE COIL COULD NOT BE DETACHED. IT WAS CONFIRMED THE POWER LIGHT ILLUMINATED AND DURING THE DETACHMENT CYCLE THE DETACHMENT LIGHT ILLUMINATED. THE COIL WAS REPLACED WITH A COMPETITIVE COIL, IT IS UNKNOWN IF THE ENPOWER CABLE WAS EXCHANGED. THERE WERE NO DAMAGES NOTED ON THE COIL PRIOR TO USE OR UPON REMOVAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES. HOWEVER, DUE TO THE EVENT THE PROCEDURE WAS DELAYED BY 10 MINUTES. THERE WERE NO PATIENT INJURIES OR COMPLICATIONS 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. THE PRODUCT HAS ALREADY BEEN DISPOSED AND IS NOT AVAILABLE FOR INVESTIGATION AS THERE WAS BLOOD ON THE PRODUCTS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6314281 ↗
• MalfunctionAug 30, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DELTAMAXX 8 X 35 (CDX180835-30/C34367) FAILED TO DETACH DURING THE PROCEDURE. THE PROCEDURE WAS FOR BRONCHIAL ARTERY EMBOLIZATION AT LEFT- INTERNAL THORACIC ARTERY USING 4FR SYSTEM. THE PATIENT'S GENDER AND AGE WERE UNKNOWN; THE LEVEL OF TORTUOUSNESS AND CALCIFICATION OF THE VESSELS WERE ALSO UNKNOWN. PRE-DEPLOYMENT ELECTRICAL CHECK INDICATED THAT THERE WERE NO ISSUES WITH THE POWER SUPPLIED; HOWEVER, THE GREEN SYSTEM READY LIGHT DIDN'T ILLUMINATE WHEN THE PHYSICIAN ATTEMPTED TO DETACH THE COMPLAINT DELTAMAXX 8 X 35. THE GREEN SYSTEM READY LIGHT ILLUMINATED WHILE RETRIEVING THE COIL, SO THE PHYSICIAN PLACED THE COIL AGAIN AND PRESSED THE DETACH BUTTON. HOWEVER THE COIL FAILED TO DETACH. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE PHYSICIAN GAVE UP PLACING THE COMPLAINT COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES AND DELAY. THERE WERE NO PATIENT INJURIES OR COMPLICATIONS REPORTED. THE ENPOWER CABLE (ECB000182-00/P11349) THAT WAS USED WITH THE COMPLAINT COIL WAS ALSO USED FOR SEVERAL OTHER COILS DURING THE PROCEDURE AND FUNCTIONED PROPERLY. THE SAME CONNECTING CABLE AND DETACH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5913494 ↗