DELTAFILL DLF180520Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886704076926), received between Oct 4, 2017 and Oct 24, 2024 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 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 16, 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.

• InjuryOct 24, 2024Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TARGETING A LEFT POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM WITH NORMAL ANATOMY USING A CEREBASE (UNKNOWN CATALOG AND LOT NUMBER), A SOFIA¿ 6F INTERMEDIATE CATHETER (MICROVENTION) AND A TOTAL OF SIX COILS. IT WAS REPORTED THAT THREE OF THE SIX COILS ¿GOT STUCK IN THE MICROCATHETER AND COULD NOT BE REMOVED.¿ THE THREE COILS WERE: A 6MM X 25CM DELTAFILL 18 (DLF180625 / 30719513), A 5MM X 20CM DELTAFILL 18 (DLF180520 / 30942962), AND A 4MM X 10CM DELTAFILL 10 (DLF100410 / 30871956). IT WAS REPORTED THAT ¿WHEN TRYING TO PULL THE FIRST COIL [THE 6MM X 25CM DELTAFILL 18 (DLF180625 / 30719513)] OUT OF THE CONCOMITANT SL-10® MICROCATHETER (STRYKER), THE PUSHER WIRE TORE OFF AND THE COIL BECAME STUCK IN THE MICROCATHETER. THE MICROCATHETER THEREFORE, HAD TO BE REMOVED. IT WAS REPORTED THAT PRIOR TO THIS COIL, THE PREVIOUS THREE COILS ¿COULD BE PUSHED THROUGH THE SAME [MICROCATHETER].¿ THIS FIRST SL-10® MICROCATHETER (STRYKER) WAS NOT SAVED. THE SAME INCIDENT OCCURRED TWICE MORE DURING COIL EMBOLIZATION WITH THE 5MM X 20CM DELTAFILL 18 (DLF180520 / 30942962), AND A 4MM X 10CM DELTAFILL 10 (DLF100

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20524980 ↗
• MalfunctionSep 15, 2023Break; Break

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A SPLENIC ARTERY ANEURYSM, TOWARD THE END OF THE PROCEDURE, A DELTAFILL18 5MM X 20CM COIL (DLF180520, 30611653) WAS USED AND DURING RETRIEVAL OF THE COIL, THE SHEATH GOT DAMAGED AND COULD NOT DELIVER THE COIL. FINALLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICE IS CARRY LEON MICROCATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO NECK REMODELING WAS UTILIZED. THE CAUSE OF RESHEATHING THE COIL WAS DUE TO CHANGE IN SIZE. THE MICROCOIL WAS POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE CORE WIRE WAS FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17754906 ↗
• MalfunctionSep 5, 2023Device Difficult to Setup or Prepare; Migration; Device Difficult to Setup or Prepare; Migration

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION OF A RENAL ARTERY ANEURYSM (RETREATMENT). EMBOLIZATION WAS FIRST PERFORMED WITH RUBY AND XXL COILS USING PARENT 45 GUIDECATHETER, THEN THE MICROCATHETER (MC) WAS CHANGED TO EXCELSIOR 1018 AND EMBOLIZATION WAS CONTINUED WITH SMALL DIAMETER COILS. THE DELTAFILL18 5MM X 20CM COIL WAS USED AS 6TH OR 7TH COIL, AND ATTEMPTED TO IMPLANT, BUT THE COIL DID NOT FIT WELL AND RETRIEVED. AT THAT TIME, THE DELIVERY SYSTEM DID NOT FIT INSIDE THE SHEATH AND COULD NOT BE RE-SHEATHED THE COIL. AFTER THAT, THE POSITION OF THE MC WAS CORRECTED, SEVERAL COILS WERE ADDITIONALLY IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS PERFORMED. OTHER CONCOMITANT DEVICES ARE ASAHI MEISTER 16 GUIDEWIRE, EXSELSIOR 1018 MICROCATHETER, PARENT 45 GUIDINGCATHETER. ADDITIONAL INFORMATION RECEIVED ON 16-AUG-2023 INDICATED THAT THE COIL FAILED TO FIT INSIDE THE ANEURYSM WITH THE ALREADY IMPLANTED COIL MASS. AFTER SEVERAL ATTEMPTS TO FIT THE COIL, THE COIL FINALLY FIT INSIDE THE ANEURYSM. THEN THE DETACHMENT OF THE COIL WAS COMPLETED, BUT THE POSTERIOR END OF THE COIL PROTRUDED TO THE PARE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683891 ↗
• MalfunctionJul 21, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF AN INFERIOR PANCREATICODUODENAL ARTERY ANEURYSM UNDER FLOW CONTROL, TOWARD THE END OF THE COIL EMBOLIZATION, A DELTAFILL18 5MM X 20CM (DLF180520, 30910227) WAS USED AND CHECKED FOR ELECTRICAL CONTINUITY AS USUAL. HOWEVER, THE INDICATOR LED ON THE CONTROL BOX DID NOT ILLUMINATE. TO AVOID THE INABILITY TO DETACH, THE DELTAFILL18 WAS REPLACED TO ANOTHER PRODUCT OF THE SAME TYPE, AND THE LED ILLUMINATED WITHOUT ANY PROBLEM, PERFORMED THE EMBOLIZATION AND COMPLETED THE PROCEDURE. A TOTAL OF 23 DELTAFILL18 COILS WERE USED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370247 ↗
• MalfunctionNov 14, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE THAT WAS TARGETING A LESION ON THE INTERNAL THORACIC ARTERY, THE ¿PARENT¿ CATHETER WAS INSERTED AND DELIVERED TO THE ENTRANCE OF THE INTERNAL THORACIC ARTERY. THE MAIN VESSEL WAS EMBOLIZED WITH A MICROCATHETER, A MARVEL® MICROCATHETER (TOKAI MEDICAL PRODUCTS). THE PARENT CATHETER WAS ABLE TO APPROACH THE EMBOLIZED REGION AND THE MICROCATHETER WAS USED. THE CATHETER WAS FLUSHED AND THE COMPLAINT COIL, A 5MM X 20CM DELTAFILL 18 (DLF180520 / K10632) WAS USED AS THE FIRST COIL. ANCHORING WAS APPLIED AND THE COMPLAINT COIL WAS RE-SHEATHED TO BE SHAPED AS INTENDED. HOWEVER, THE COMPLAINT COIL WAS ¿UNABLE TO BE PUSHED AT ALL¿ EVEN THOUGH THE COMPLAINT COIL WAS RETRACTED, IT DID NOT SHOW IT RETRACTED ON THE IMAGE(S). THE PHYSICIAN JUDGED THE COMPLAINT COIL TO BE UNRAVELED. THE COMPLAINT COIL WAS RETRACTED TOGETHER WITH THE MICROCATHETER INTO THE PARENT CATHETER. THE COMPLAINT COIL AND THE MICROCATHETER WERE REPLACED WITH OTHER DEVICES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. IT WAS REPORTED THAT CONTINUOUS FLUSH WAS NOT MAINTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15792121 ↗
• InjuryDec 29, 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) MALE PATIENT WITH A PAST MEDICAL HISTORY OF HYPERTENSION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), AND SMOKING (PREVIOUS) UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF AN INFRARENAL 48MM ABDOMINAL AORTIC ANEURYSM (AAA) AND EXPERIENCED AN ENDOLEAK (TYPE UNKNOWN) 362 DAYS AFTER THE PROCEDURE. THE PROCEDURE WAS AN INITIAL ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) OF AAA. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. STENT GRAFT USED WAS THE AFX ENDOVASCULAR AAA SYSTEM. A TOTAL OF THREE SPECTRA DELTAFILL18 (CERENOVUS) COILS: ONE (1) 6MM X 25CM DELTAFILL 18 (DLF180625 / LOT# UNKNOWN) AND TWO (2) 5MM X 20CM DELTAFILL 18 (DLF180520 / LOT# UNKNOWN) WERE IMPLANTED AT THE LUMBAR ARTERY. THERE WERE REPORTEDLY NO PROCEDURAL COMPLICATIONS. THE COIL EMBOLIZATION WAS CONSIDERED SUCCESSFUL. FLUOROSCOPY TIME WAS 56 MINUTES. THE PATIENT WAS HOSPITALIZED NINE DAYS. THE COILS REMAIN IMPLANTED AND ARE THUS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Aneurysm

  MAUDE report 13112174 ↗
• InjuryDec 29, 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) MALE PATIENT WITH A PAST MEDICAL HISTORY OF HYPERTENSION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), AND SMOKING (PREVIOUS) UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF AN INFRARENAL 48MM ABDOMINAL AORTIC ANEURYSM (AAA) AND EXPERIENCED AN ENDOLEAK (TYPE UNKNOWN) 362 DAYS AFTER THE PROCEDURE. THE PROCEDURE WAS AN INITIAL ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) OF AAA. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. STENT GRAFT USED WAS THE AFX ENDOVASCULAR AAA SYSTEM. A TOTAL OF THREE SPECTRA DELTAFILL18 (CERENOVUS) COILS: ONE (1) 6MM X 25CM DELTAFILL 18 (DLF180625 / LOT# UNKNOWN) AND TWO (2) 5MM X 20CM DELTAFILL 18 (DLF180520 / LOT# UNKNOWN) WERE IMPLANTED AT THE LUMBAR ARTERY. THERE WERE REPORTEDLY NO PROCEDURAL COMPLICATIONS. THE COIL EMBOLIZATION WAS CONSIDERED SUCCESSFUL. FLUOROSCOPY TIME WAS 56 MINUTES. THE PATIENT WAS HOSPITALIZED NINE DAYS. THE COILS REMAIN IMPLANTED AND ARE THUS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Aneurysm

  MAUDE report 13112170 ↗
• MalfunctionAug 27, 2021Material Rupture; Stretched; Failure to Advance; Material Rupture; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 7MM X 21CM GALAXY G3 COIL (GLY120721 / L15620) AND THE 5MM X 20CM DELTAFILL 18 COIL (DLF180520 / L16341) WERE INSERTED INTO A CONCOMITANT PROWLER SELECT PLUS MICROCATHETER (CATALOG AND LOT NUMBER UNKNOWN) BUT THERE WAS A SLIGHT RESISTANCE FELT. THE PHYSICIAN KEPT PUSHING THEM BUT THEY WERE NOT ABLE TO ADVANCE. IT WAS REPORTED THAT THE PHYSICIAN CHECKED HIS HAND, HE NOTICED THAT THE SHEATHS ON THE COILS WERE TORN AND THE DELIVERY WIRES WERE PROTRUDING FROM THE SHEATHS. THE PHYSICIAN ATTEMPTED TO RETRACT THE COILS BUT THE COIL COMPONENTS BECAME DAMAGED AND WERE NO LONGER ABLE TO BE USED. IT WAS REPORTED THAT THE COIL COMPONENTS MAY HAVE GOTTEN STUCK ON THE PEEL AWAY PARTS AND BECAME STRETCHED. THE COILS WERE REPLACED AD THE PROCEDURE RESUMED TO COMPLETION. THE COMPLAINT PRODUCTS ARE REPORTED AS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSES. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380467 ↗
• MalfunctionJun 1, 2021Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR BLEEDING AFTER DISTAL PANCREATECTOMY WITH EN BLOC CELIAC AXIS RESECTION (DP-CAR), THE COMMON HEPATIC ARTERY (CHA) WHERE HAD BLEEDING WAS EMBOLIZED. THIS PROCEDURE WAS TREATED BY TRIAXIAL. THREE RUBY COILS WERE INSERTED FROM A MICROCATHETER (HF) AND THEY WERE IMPLANTED. TWO ¿COILS WERE IMPLANTED FROM A MICROCATHETER (CARNELIAN MARVEL NON-TAPER, TOKAI MEDICAL PRODUCTS). THE 5MM X 20CM DELTAFILL18 COIL WAS USED AS THE SIXTH COIL BUT THERE WAS AN INTENSIVE RESISTANCE FELT AFTER IT ADVANCED THROUGH THE UNSPECIFIED MICROCATHETER 50CM. THE COMPLAINT COIL WAS REMOVED AND THE MICROCATHETER WAS FLUSHED. THE PHYSICIAN TRIED AGAIN BUT THERE WAS A RESISTANCE FELT AFTER THE COMPLAINT COIL ADVANCED 30 CM. THE PHYSICIAN RETRACTED THE DELIVERY WIRE TO REMOVE THE COMPLAINT COIL ITSELF, BUT IT WAS PREMATURELY DETACHED. AFTER THAT, ANGIOGRAPHY SHOWED HEMOSTASIS WAS ARCHIVED. THE PROCEDURE WAS COMPLETED. EXCESSIVE FORCE WAS NOT APPLIED TO THE DEVICE. THE DEVICES WERE USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913916 ↗
• InjuryNov 12, 2019Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM AT THE RENAL ARTERY, THE 5MM X 20CM DELTAFILL 18 COIL (DLF180520 / S14119) WAS THE TENTH COIL USED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL BUT COULD NOT GET THE COIL TO DETACH; THEN IT WAS REPORTED THAT THE COIL BECAME DETACHED AT THE DISTAL END OF THE MICROCATHETER (UNKNOWN BRAND) AND IT WAS PUSHED BY A PUSHER INTO THE ANEURYSM AND WAS IMPLANTED. ANOTHER COIL, THE 4MM X 15CM DELTAFILL 18 COIL (DLF180415 / S14235) WAS THEN USED BUT THIS COIL WAS ALSO REPORTED TO HAVE DETACHMENT ISSUE; THOUGH THE PHYSICIAN ATTEMPTED TO DETACH THE COIL FIVE TIMES. THE PROCEDURE WAS COMPLETED USING THE TARGET®COIL (STRYKER). A TOTAL OF FIFTEEN SPECTRA COILS WERE USED IN THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Code Available

  MAUDE report 9313107 ↗
• MalfunctionMay 30, 2018Positioning Failure; Positioning Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE DELTAFILL18 5 MM X 20 CM (DLF180520 / S14202) COULD NOT BE DETACHED. IT WAS USED WITH THE ENPOWER CONTROL CABLE (ECB00018200 / S14045) WHICH HAD NO ISSUE. THE COIL WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETE WITHOUT FURTHER ISSUE OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT; NO UNINTENDED DETACHMENT IN THE VESSEL OR IN THE MICROCATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7555429 ↗
• MalfunctionOct 4, 2017Positioning Failure; Kinked; Positioning Failure; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING TREATMENT OF AN INFERIOR MESENTERIC ANEURYSM, A DELTAFILL18 (DLF180520, S12936) FAILED TO DETACH. PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT PERFORMED. THE DELTAFILL18 WAS ATTEMPTED TO DETACHED AT THE LESION AND THE PHYSICIAN PRESSED THE DEPLOYMENT BUTTON, BUT IT WAS NOT DETACHED ALTHOUGH THE SIGNAL BEEP WAS AUDIBLE. THE BUTTON WAS PRESSED SEVERAL TIMES BUT THE ISSUE CONTINUED. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND WAS REPLACED WITH ANOTHER ONE (UNKNOWN LOT# AND CATALOG#). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY WITH 2 COILS AFTER REPLACING THE COIL. 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. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6913961 ↗