DELTAMAXX CERECYTE CDX180415-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10878528008559), received between Oct 7, 2016 and Dec 23, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (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, A (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 13080211 ↗
• MalfunctionFeb 2, 2017Kinked; Premature Activation; Physical Resistance; Kinked; Premature Activation; Physical Resistance

  THE CONTACT FROM THE FACILITY REPORTED THAT DURING COIL EMBOLIZATION OF AN ANEURYSM AT THE RIGHT RENAL ARTERY THERE WAS RESISTANCE WHEN THE DELTAMAXX (CDX180415-30/ C39151) WAS ADVANCED AND RETRIEVED THROUGH THE MICROCATHETER AND THE EMBOLIC COIL DETACHED FROM THE DELIVERY WIRE DURING RETRIEVAL. THE PROCEDURE WAS THE COIL EMBOLIZATION OF AN ANEURYSM AT THE RIGHT RENAL ARTERY (BLEEDING DUE TO TRAFFIC ACCIDENT). THE PATIENT¿S VESSEL WAS MILDLY TORTUROUS AND UNKNOWN CALCIFIED. A SHEATH INTRODUCER (MEDIKIT), A GUIDEWIRE (APPROACH WIRE,TORAY MEDICAL), A GUIDING CATHETER(ANGIOGRAPHIC CATHETER), A MICRO CATHETER (ESTREAM, TORAY MEDICAL) AND ENPOWER DETACHMENT ACCESSORIES WERE ALSO USED FOR THIS PROCEDURE. THE PUNCTURE WAS PERFORMED FORM RIGHT FEMORAL ARTERY AND A GUIDE WIRE, A MICRO CATHETER, A GUIDING CATHETER WERE INSERTED. THE MICRO CATHETER ACCESSED TO THE RIGHT RENAL ARTERY, AND THE COIL EMBOLIZATION WAS PERFORMED. THE DELTAMAXX (COMPLAINT PRODUCT) WAS USED FOR 1ST COIL. AN ADJUNCT WAS PREPARED WITH THE COIL AND THE PHYSICIAN INSERTED THE COIL INTO THE MICRO CATHETER. THE TYPE OF ADJUNCT IS UNKNOWN. THE DELIVERY WIRE WAS ADVANCED ALTHOUGH THERE WAS RESISTANCE FELT AT THE MIDDLE PORTI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6298930 ↗
• MalfunctionDec 15, 2016Stretched; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING THE COIL EMBOLIZATION PROCEDURE THE FIRST COIL USED A DELTAMAXX CERECYTE (CDX18041530/C38845) COIL COULD NOT BE ADVANCED VIA THE DISTAL SHAFT OF THE MICROCATHETER (TYPE/LOT UNKNOWN). THE COIL WAS RESHAPED BEFORE THIS ISSUE. THE COIL WAS WITHDRAWN STILL ATTACHED TO THE DELIVERY SYSTEM; HOWEVER WAS FOUND TO BE STRETCHED. ONLY THE COMPLAINT COIL WAS REMOVED FROM THE PATIENT; THE REPORTED EVENT DID NOT REQUIRE EXCHANGE OF THE MICROCATHETER AND THE SAME CATHETER WAS USED WITH A NEW COIL TO COMPLETE THE PROCEDURE. THERE WERE NO KINKS NOTED ON THE MICROCATHETER OR DAMAGES NOTED ON THE COMPLAINT COIL PRIOR TO USE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AT ALL TIMES. THERE WAS NO REPORT ON THE PATIENT INJURY. THERE WERE NO INTRA OR POST PROCEDURAL COMPLICATIONS OR SURGICAL DELAYS RELATED TO DEVICE OR REPORTED EVENT. PATIENT INFORMATION IS UNKNOWN, PATIENT OUTCOME WAS REPORTED TO BE FINE. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6176558 ↗
• MalfunctionNov 9, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION, IT WAS REPORTED THAT A DELTAMAXX COIL (CDX18041530/C41628) FAILED TO DETACH. THE PROCEDURE WAS PARTIAL SPLENIC ARTERY EMBOLIZATION AT THE PERIPHERAL LIENAL ARTERY. THE PATIENT WAS A (B)(6) WHOSE VESSELS WERE MILDLY TORTUROUS AND NOT CALCIFIED. THE GUIDING CATHETER AND THE MICRO CATHETER WERE ACCESSED TO THE LESION FORM THE RIGHT FEMORAL ARTERY. THE DELTAMAXX (COMPLAINT PRODUCT) WAS INSERTED AS 1ST COIL, AND THE PHYSICIAN TRIED TO DETACH THE COIL. HOWEVER IT WAS FOUND THAT THE GREEN SYSTEM READY LIGHT OF THE ENPOWER BOX DID NOT ILLUMINATE. THE BOX WAS REBOOTED AND CONNECTOR WAS RECONNECTED TO THE CABLE BUT THE LIGHT DID NOT ILLUMINATE. THEREFORE THE COIL WAS REPLACED WITH ANOTHER ONE. AFTER WHICH 3 COILS (IDC 4 MM / DELTAMAXX 3MM /CASHMERE 3MM) AND ALSO MICRUS PRODUCTS WERE USED IN ORDER WITHOUT ANY ISSUES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. 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 VISIBL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6089287 ↗
• MalfunctionNov 4, 2016Failure to Advance; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE RESISTANCE WAS EXPERIENCED WITH A MICROCATHETER WHEN USING A DELTAMAXX COIL (CDX18041530/C39878). THE PROCEDURE WAS COIL EMBOLIZATION OF A RUPTURED ANEURYSM AT THE RIGHT INTERNAL CAROTID-POSTERIOR COMMUNICATING SEGMENT. THE PATIENT WAS A (B)(6) FEMALE WHOSE VESSELS WERE MODERATELY TORTUROUS AND HEAVILY CALCIFIED. A GUIDING CATHETER (6F 90CM SHUTTLE SHEATH, COOK INC) WAS GUIDED TO THE RIGHT ICA AFTER WHICH A MICRO CATHETER (SL 10, STRYKER) WAS INSERTED. A COMPETITOR'S COIL (TARGET COIL XL, STRIKER) GOT EMBEDDED INSIDE THE MICROCATHETER BUT DID NOT DETACH. ANOTHER MICRO CATHETER (HEADWAY, TERUMO) WAS USED INTO WHICH ANOTHER COIL (TARGET COIL, STRIKER) GOT EMBEDDED. AFTER THIS COIL, THREE COILS WERE DETACHED. THE ORDER OF THE COILS WAS AS FOLLOWS; 7*33 DELTAMAXX, 5*20 DELTAMAXX, AND 5*15 TARGET COIL XL. ALL THESE FIVE COILS WERE DETACHED WITHOUT ANY ISSUES. THE COMPLAINT COIL WAS THEN PREPARED PER THE IFU PRIOR TO USE AND WAS INSERTED INTO THE MICRO CATHETER (SL 10, STRYKER). HOWEVER, THERE WAS RESISTANCE FELT WHEN THE COMPLAINT COIL ADVANCED APPROXIMATELY 30 CM INWARD, THE COIL WAS REMOVED FROM THIS MICRO CATHETER. ANOTHE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6078412 ↗
• MalfunctionOct 7, 2016Premature Activation; Stretched; Premature Activation; Stretched

  THE CONTACT FROM THE FACILITY REPORTED THAT DURING COIL EMBOLIZATION OF AN ANEURYSM AT A BLOOD VESSEL IN THE VICINITY OF PELVIS TWO DELTAMAXX COILS (CDX180415-30/C39578, AND CDX180625-30/C39754) COULD NOT BE RESHEATHED. THE PATIENT WAS A MALE OF UNKNOWN AGE; THE LEVEL OF TORTUOUSNESS WAS UNKNOWN, AND NO CALCIFICATION OF THE VESSELS. A MEISTER (ASAHI INTECC), AND A PROGREAT (TERUMO) WERE USED FOR THIS PROCEDURE. WHEN THE PHYSICIAN TRIED TO RETRIEVE AND RE-SHEATH THE COMPLAINT DELTAMAXX (TWO OF THEM), THE SHEATH WAS SPLIT OPEN AND COULDN'T RE-SHEATH. THE PHYSICIAN GAVE UP RETRIEVING THE BOTH COILS AND USED SPARE 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 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 MICROCATHETER. THE COMPLAINT PRODUCT WILL BE RETURNED FOR THE INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE. PRODUC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6011534 ↗