DELTAMAXX CERECYTE CDX180312-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10878528008542), received between Oct 25, 2016 and Jan 28, 2022 — classified as 5 injuries, 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF HYPERTENSION, CORONARY ARTERY DISEASE (CAD), DYSLIPIDEMIA, RENAL INSUFFICIENCY, AND SMOKING (PREVIOUS) UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF A 63MM INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE AND EXPERIENCED A TYPE II ENDOLEAK OF THE LUMBAR ARTERY 110 DAYS FOLLOWING THE PROCEDURE. ENDOVASCULAR REINTERVENTION WAS PERFORMED AS TREATMENT. THE PATIENT THEN UNDERWENT ENDOVASCULAR REINTERVENTION OF A TYPE IB ENDOLEAK 113 DAYS POST-PROCEDURE. THE STUDY PROCEDURE WAS REINTERVENTION OF AAA. THE INITIAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED 1,864 DAYS PRIOR. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. ONE (1) CERENOVUS COIL, A 3MM X 12CM DELTAMAXX COILS (CDX18031230 / UNKNOWN LOT NUMBER) WAS IMPLANTED AT THE LUMBAR ARTERY. COIL EMBOLIZATION WAS CONSIDERED SUCCESSFUL. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS.

  Patient problems: Aneurysm

  MAUDE report 13388938 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE AAA STUDY, A (B)(6) MALE PATIENT WITH A PAST MEDICAL HISTORY OF DYSLIPIDEMIA AND SMOKING (PREVIOUS) UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF A 54MM INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE AND EXPERIENCED TYPE II ENDOLEAK 221 DAYS AFTER THE PROCEDURE REQUIRING REINTERVENTION. THE PATIENT ALSO HAD A TYPE II ENDOLEAK OF A PREVIOUSLY UNIDENTIFIED VESSEL 161 DAYS POST-PROCEDURE. THE STUDY PROCEDURE WAS REINTERVENTION OF AAA; THE INITIAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED 1,993 DAYS PRIOR TO THIS PROCEDURE. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. TWO (2) 3MM X 12CM DELTAMAXX COILS (CDX18031230 /UNKNOWN LOT NUMBER) WERE IMPLANTED AT THE LUMBAR ARTERY. THE COIL EMBOLIZATION WAS DEEMED SUCCESSFUL. THERE WERE NO PROCEDURAL COMPLICATIONS. THE PATIENT WAS HOSPITALIZED TEN DAYS. THE COMPLAINT COILS REMAIN IMPLANTED AND ARE THUS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Aneurysm

  MAUDE report 13388733 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE AAA STUDY, A (B)(6) MALE PATIENT WITH A PAST MEDICAL HISTORY OF DYSLIPIDEMIA AND SMOKING (PREVIOUS) UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF A 54MM INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE AND EXPERIENCED TYPE II ENDOLEAK 221 DAYS AFTER THE PROCEDURE REQUIRING REINTERVENTION. THE PATIENT ALSO HAD A TYPE II ENDOLEAK OF A PREVIOUSLY UNIDENTIFIED VESSEL 161 DAYS POST-PROCEDURE. THE STUDY PROCEDURE WAS REINTERVENTION OF AAA; THE INITIAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED 1,993 DAYS PRIOR TO THIS PROCEDURE. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. TWO (2) 3MM X 12CM DELTAMAXX COILS CDX18031230 / UNKNOWN LOT NUMBER) WERE IMPLANTED AT THE LUMBAR ARTERY. THE COIL EMBOLIZATION WAS DEEMED SUCCESSFUL. THERE WERE NO PROCEDURAL COMPLICATIONS. THE PATIENT WAS HOSPITALIZED TEN DAYS. THE COMPLAINT COILS REMAIN IMPLANTED AND ARE THUS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Aneurysm

  MAUDE report 13388721 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, AN (B)(6) FEMALE PATIENT WITH A PAST MEDICAL HISTORY OF HYPERTENSION AND DYSLIPIDEMIA UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF A 77MM INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE AND EXPERIENCED A TYPE II ENDOLEAK 178 DAYS FOLLOWING THE PROCEDURE. OPEN REINTERVENTION WAS PERFORMED AS TREATMENT. IT IS NOT KNOWN WHETHER THE TYPE II ENDOLEAK WAS ASSOCIATED WITH THE TARGET VESSEL. THE STUDY PROCEDURE WAS REINTERVENTION OF AAA. THE INITIAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED 402 DAYS PRIOR. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. TWO (2) 3MM X 12CM DELTAMAXX COILS (CDX18031230 /UNKNOWN LOT NUMBER) WERE IMPLANTED AT THE LUMBAR ARTERY. COIL EMBOLIZATION WAS CONSIDERED SUCCESSFUL. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS.

  Patient problems: Aneurysm

  MAUDE report 13335221 ↗
• InjuryJan 24, 2022Adverse 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 AND DYSLIPIDEMIA UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF A 77MM INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE AND EXPERIENCED A TYPE II ENDOLEAK 178 DAYS FOLLOWING THE PROCEDURE. OPEN REINTERVENTION WAS PERFORMED AS TREATMENT. IT IS NOT KNOWN WHETHER THE TYPE II ENDOLEAK WAS ASSOCIATED WITH THE TARGET VESSEL. THE STUDY PROCEDURE WAS REINTERVENTION OF AAA. THE INITIAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED 402 DAYS PRIOR. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. TWO (2) 3MM X 12CM DELTAMAXX COILS (CDX18031230 / UNKNOWN LOT NUMBER) WERE IMPLANTED AT THE LUMBAR ARTERY. COIL EMBOLIZATION WAS CONSIDERED SUCCESSFUL. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS.

  Patient problems: Aneurysm

  MAUDE report 13335219 ↗
• MalfunctionSep 27, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE COIL INTRODUCER OF A DELTAMAXX COIL (CDX18031230/S11045) GOT DAMAGED AND DURING PRODUCT ANALYSIS, IT WAS CONFIRMED THAT THE COIL WAS STRETCHED. THE PROCEDURE WAS PRE-SG TYPE II ENDOLOEAK PROPHYLAXIS COIL EMBOLIZATION OF AN ANEURYSM AT THE INFERIOR MESENTERIC ARTERY AND THE LUMBAR ARTERY. THE PATIENT WAS A MALE WHOSE VESSEL WAS MILDLY TORTUROUS AND NOT CALCIFIED. THE TARGET BLOOD VESSEL WAS ONE LOWER MESENTERIC ARTERY AND TWO LUMBAR ARTERIES. A PUNCTURE WAS MADE IN THE RIGHT FEMORAL ARTERY AND A GUIDING CATHETER, A GUIDEWIRE AND MICRO CATHETER WERE INSERTED. CONTRAST WAS PERFORMED WITH THE GUIDING CATHETER AND COIL EMBOLIZATION WAS STARTED AT THE LOWER MESENTERIC ARTERY. THE DELTAMAXX (COMPLAINT PRODUCT) WAS SELECTED AS THE 1ST COIL AND IT WAS PREPARED ACCORDING TO IFU. THE COIL WAS INSERTED BUT IT WAS UNDER SIZED FOR THE VASCULAR DIAMETER. THE PHYSICIAN TRIED TO RE-SHEATH THE COIL BUT ITS INTRODUCER GOT DAMAGED AND THE COIL COULD NOT BE RE-SHEATHED. THE COIL WAS REMOVED FROM THE PATIENT¿S BODY AND OTHER COILS (DELTAMAXX5MMX20CM/ DELTAMAXX4MMX15CM) WERE PLACED WITHOUT ANY PROBLEM. REPORTEDLY THERE WERE NO ISSUES WHEN THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6899412 ↗
• MalfunctionSep 4, 2017Stretched; Physical Resistance; Stretched; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE COIL EMBOLIZATION, THE DELTAMAXX COIL (CDX18031230/ S10390) COULD NOT BE ADVANCED VIA THE UNSPECIFIED MICROCATHETER, AND DURING PRODUCT ANALYSIS, IT WAS FOUND THAT THE COIL HAD PROTRUDED THROUGH THE INTRODUCER AND WAS STRETCHED. THEY WITHDREW THE COIL AND USED A NEW COIL TO COMPLETE THE PROCEDURE. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THE MICROCATHETER AND DELTAMAXX DID NOT APPEAR DAMAGED DURING THE PROCEDURE. THE PRODUCTS WERE PREPPED AND USED AS PER THE IFU. THERE WAS NO REPORT OF PATIENT INJURY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6840949 ↗
• MalfunctionMay 10, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION FOR A TYPE II ENDOLEAK AT THE INFERIOR MESENTERIC ARTERY, A DELTAMAXX COIL (CDX18031230/S11837) FAILED TO DETACH. INITIALLY A PRESIDIO COIL WAS PLACED. AS THE SECOND COIL, THE COMPLAINT DELTAMAXX WAS TAKEN OUT FROM ITS PACKAGE. PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED, AND THE COIL WAS INSERTED, BUT THE COIL COULD NOT BE DETACHED WHEN THE DETACHMENT BUTTON WAS PRESSED. THE PHYSICIAN PRESSED THE BUTTON AGAIN, BUT IT WAS FOUND THAT THE LIGHT HAD GONE OFF, SO THE DELIVERY WIRE WAS WITHDRAWN AND THE COIL WAS REMOVED. THE COIL WAS REPLACED WITH ANOTHER DELTAMAXX, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY PLACING 10 COILS 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 OR AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. IT WAS REPORTED THAT THE PRODUCT WOULD BE RETURNED FOR INVESTIGATION. N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6557031 ↗
• MalfunctionApr 19, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION FOR PLACING A RESERVOIR, A DELTAMAXX COIL (CDX180312-30, S11663) FAILED TO DETACH. THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE. IT DID NOT POWER-ON AND THE COIL COULD NOT BE DETACHED. THEREFORE, THE COIL WAS REPLACED WITH ANOTHER ONE (SAME SIZE). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES. 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 INSTRUCTIONS FOR USE (IFU), AND A CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO OR AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6504288 ↗
• MalfunctionMar 2, 2017Aborted Charge; Failure to Advance; Aborted Charge; Failure to Advance

  THE CONTACT FROM THE FACILITY REPORTED THAT DURING COIL EMBOLIZATION OF A SPLENIC ARTERY AT THE ABDOMEN THE DELTAMAXX (CDX180312-30/ S10218) WAS STUCK IN THE MICROCATHETER AND THE INTRODUCER SHEATH GOT DAMAGED. THE PROCEDURE WAS THE COIL EMBOLIZATION OF A SPLENIC ARTERY AT THE ABDOMEN. THE PATIENT¿S INFORMATION WAS UNKNOWN. THE PATIENT¿S VESSELS WERE HEAVILY TORTUOUS. A GUIDEWIRE (RADIFOCUS GT GW, TERUMO), A MICROCATHETER (SL10, STRYKER), A Y-CONNECTOR (UNKNOWN), AND AN ENPOWER WERE ALSO USED FOR THIS PROCEDURE. THE COMPLAINT COIL WAS INSERTED, BUT IT GOT STUCK IN THE MICRO CATHETER AND THE INTRODUCER SHEATH GOT DAMAGED. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. 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 AND AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICRO CATHETER. THE PRODUCT HAS ALREADY BEEN DISPOSED AND NOT AVAILAB

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6375136 ↗
• MalfunctionNov 7, 2016Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A COIL EMBOLIZATION OF A DURAL ARTERIOVENOUS FISTULA A DELTAMAXX COIL (CDX180312-30, C30606) WAS BEING USED AND FAILED TO DETACH. AN APPROACH WAS TAKEN FROM THE FEMORAL VEIN WITH THE GUIDING CATHETER. THE MICRO CATHETER WAS GUIDED TO THE TARGET LESION AND SOME COILS WERE IMPLANTED. THE TARGET ANEURYSM WAS LOCATED IN THE TRANSVERSE-SIGMOID SINUS. THE SEVENTH COIL WAS A DELTAMAXX AND WAS IMPLANTED. REPORTEDLY, ANOTHER DELTAMAXX (COMPLAINT PRODUCT) WAS DELIVERED TO THE LESION, BUT THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE AFTER CONNECTING THE CABLE, ALTHOUGH THE LIGHT TURNED ON WITHOUT ISSUE DURING PREPARATION. THE CABLE WAS REPLACED WITH ANOTHER CABLE AND THE ENPOWBOX WAS REPLACED WITH ANOTHER ENPOWBOX BUT THE LIGHT DID NOT ILLUMINATE. THEREFORE THE COMPLAINT COIL WAS REMOVED WITHOUT DEPLOYMENT. ANOTHER NEW DELTAMAXX WAS EMBEDDED. 17 COILS (CNV AND NON-CNV) WERE IMPLANTED IN TOTAL. THE PATIENT WAS A FEMALE, BUT HER AGE WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENTVESSEL WAS MILDLY TORTUOUS AND NOT CALCIFIED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES. HOWEVER, DUE TO THE EVENT IT WAS DELAYED F

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6082591 ↗
• MalfunctionOct 25, 2016Positioning Failure; Positioning Failure

  A REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION AT THE LATERAL SINUS FOR DURAL ARTERIOVENOUS FISTULA, THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE AFTER CONNECTING THE DELTAMAXX (CDX18031230/C41845) TO THE ENPOWER CONTROL CABLE (ECB00018200/P11371). THE EXCELSIOR 1018 MICROCATHETER HAD BEEN INSERTED TO THE TARGET LESION. FOUR COILS (DELTAMAXX 3X12) WERE PLACED, AND THE COMPLAINT DELTAMAXX WAS USED FOR THE FIFTH COIL. HOWEVER, THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE AFTER CONNECTING THE CABLE. THE CABLE WAS RE-CONNECTED SEVERAL TIMES AND THE CONTROL BOX WAS REBOOTED. THEN, THE 2ND RED LIGHT ILLUMINATED, AND THE COIL COULD NOT BE DETACHED. THE COIL WAS REPLACED WITH ANOTHER COIL (NON-CODMAN ). AFTER THE PROCEDURE, IT WAS CONFIRMED THAT THE GREEN SYSTEM READY LIGHT ILLUMINATED, BUT THE COIL COULD NOT BE DETACHED WHEN CONNECTING. IT WAS UNKNOWN IF A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED OR IF ALL CONNECTIONS HAD FIT PROPERLY WITHOUT NEED FOR EXCESSIVE FORCE. 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 INS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6055488 ↗