DELTAFILL DLF181855Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704077152), received between Apr 24, 2018 and Nov 5, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Stretched” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 5, 2025Stretched; Failure to Advance; Stretched; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE PROCEDURE WAS A COIL EMBOLIZATION OF INTERNAL ILIAC ARTERY TO TREAT ABDOMINAL AORTIC ANEURYSM PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). A 4FR ANGIOGRAPHIC CATHETER WAS INSERTED TO RIGHT INTERNAL ILIAC ARTERY VIA CONTRALATERAL APPROACH. THEN, VIA THE ANGIOGRAPHIC CATHETER, 18-MM AND 15-MM INTERLOCK35 (BSJ) WERE INSERTED AND PERFORMED ANCHORING. CARRYLEON WAS INSERTED INTO THE 4FR ANGIOGRAPHIC CATHETER, AND THE A DELTAFILL18 18MM X 55CM COIL (DLF181855, 2102549S) WAS USED. DURING ADVANCEMENT OF THE DELTAFILL18 THROUGH THE MICROCATHETER (MC), THE COIL BECAME COMPLETELY STUCK. THE COIL COULD NEITHER BE ADVANCED NOR RETRACTED, AND AFTER SEVERAL PUSH-AND-PULL ATTEMPTS, THE COIL WAS ABLE TO BE RETRIEVED. WHEN THE RETRIEVED COIL WAS INSPECTED OUTSIDE THE PATIENT¿S BODY, IT APPEARED TO BE SOMEWHAT UNRAVELED, SO ITS USE WAS STOPPED. SINCE THERE WAS NO COIL OF THE SAME SIZE AVAILABLE, THE DELTAFILL18 WAS REPLACED WITH A COIL OF A DIFFERENT SPECIFICATION. THEREAFTER, THE EMBOLIZATION PROCEEDED WITHOUT SIMILAR TROUBLE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS EVENT DID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480247 ↗
• InjuryJul 25, 2022Stretched; Positioning Problem; Premature Separation; Stretched; Positioning Problem; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PLANNED ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE SPLENIC ARTERY, A PROWLER SELECT LPES MICROCATHETER (CATALOG / LOT# UNKNOWN) WAS GUIDED INTO THE ANEURYSM AFTER GUIDING THE PARENT CATHETER INTO THE COMMON HEPATIC ARTERY. THEN SEVEN (7) DELTA COILS ¿WERE USED FROM FRAMES TO EMBOLIZE THE INSIDE OF THE ANEURYSM.¿ THE COMPLAINT COIL, AN 18MM X 55CM DELTAFILL 18 (DLF181855 / 30778018) WAS USED AS THE 8TH COIL. THE TIMING THAT THE COMPLAINT COIL WAS IMPLANTED ABOUT HALF-WAY INTO THE ANEURYSM, WHEN THE MICROCATHETER KICKED BACK AND DEFLECTED IN A LOOP. WHEN THE MICROCATHETER WAS PULLED INTO THE PARENT CATHETER TO REDUCE DEFLECTION, THE COIL WAS UNINTENTIONALLY AND PREMATURELY DETACHED. AN ATTEMPT WAS MADE TO REMOVE THE PREMATURELY DETACHED COIL USING A SNARE. THE COIL WAS UNRAVELED AND ONLY A PART OF THE COIL WAS ABLE TO BE REMOVED FROM THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED WITH PART OF THE COIL REMAINING IN THE PATIENT¿S BODY IN AN UNINTENDED STATE. THE COMPLAINT DOCUMENTED THAT THE COIL WAS PARTIALLY IMPLANTED WITHIN THE ANEURYSM IN THE SPLENIC ARTERY SO THAT THE COIL FLOWS FROM THE SPLENIC ARTERY TO TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099375 ↗
• 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, DIABETES, CORONARY ARTERY DISEASE, CEREBROVASCULAR DISEASE, DYSLIPIDEMIA, AND SMOKING (PREVIOUS) UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF AN INFRARENAL 55MM ABDOMINAL AORTIC ANEURYSM (AAA) AND EXPERIENCED A VESSEL DISSECTION OR PERFORATION DURING THE PROCEDURE. THE PROCEDURE WAS AN INITIAL ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR (EVAR). THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. STENT GRAFT USED WAS A GORE EXCLUDER AAA-ENDOPROSTHESIS. A TOTAL OF FOUR SPECTRA (CERENOVUS) COILS WERE IMPLANTED AT THE INTERNAL ILIAC ARTERY (IIA): ONE 20MM X 60CM DELTAFILL18 (DLF182060 / LOT# UNKNOWN), ONE 22MM X 60CM DELTAFILL18 (DLF182260 / LOT# UNKNOWN), ONE 18MM X 55CM DELTAFILL18 (DLF181855 / LOT# UNKNOWN), AND ONE 10MM X 40CM DELTAFILL18 (DLF181040 / LOT# UNKNOWN). FLUOROSCOPY TIME WAS 57 MINUTES. THE COIL EMBOLIZATION WAS DEEMED SUCCESSFUL. THE PATIENT WAS HOSPITALIZED TEN DAYS. THE COILS ARE NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 13112383 ↗
• MalfunctionJul 13, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A PRE-STENT GRAFT COIL EMBOLIZATION AT THE INTERNAL ILIAC ARTERY FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVA), A DELTAFILL18 18MM X 55CM (DLF181855, L14271) WAS USED BUT IT WAS NOT ABLE TO BE DETACHED. ENERGIZATION WAS REPEATED SEVERAL TIMES, BUT THE SAME ISSUE CONTINUED. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. IT WAS NOT CLEAR IF PRE-DETACHMENT ELECTRICAL CHECK WAS DONE. THERE WAS NO REPORT OF THE ACTUAL COIL BEING STRETCHED OR DAMAGED WHEN REMOVED FROM THE PATIENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. ADEQUATE FLUSH WAS NOT MAINTAINED THROUGH THE DEVICES. AN UNSPECIFIED MICROCATHETER (COILING SUPPORT) AND A DETACHABLE CONTROL BOX 2 (DCB2000500) WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158048 ↗
• MalfunctionNov 19, 2018Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED VISCERAL ANEURYSM AT THE SPLANCHNIC ARTERY, THE PHYSICIAN WAS ATTEMPTING TO CHANGE THE POSITION OF THE DELTAFILL 18 18MM X 55CM COIL (DLF181855 / L11616) WHEN THE DELIVERY WIRE WAS WITHDRAWN TO INSERT THE COIL AGAIN, THE COIL BECAME UNRAVELED. THE COIL WAS REPLACED WITH ANOTHER DELTAFILL 18 OF THE SAME PRODUCT CODE DLF181855 AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES 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. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE DELTAFILL 18 18MM X 55CM COIL WAS REPORTED AS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8087159 ↗
• MalfunctionApr 24, 2018Difficult To Position; Premature Activation; Activation, Positioning or Separation Problem; Difficult To Position; Premature Activation; Activation, Positioning or Separation Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, AFTER THE CONTRAST CATHETER WAS ADVANCED FROM THE FEMORAL ARTERY, IT WAS PLACED AT THE INTROITUS PART OF THE LEFT INTERNAL ILIAC ARTERY (IIA). THE PROWLER SELECT PLUS MICROCATHETER (606S255FX / 17745485) WAS ADVANCED BUT DUE TO THE HEAVY TORTUOUSNESS OF THE INTROITUS PORTION FROM THE EXTERNAL ILIAC ARTERY (EIA) TO THE IIA, THE CONTRAST CATHETER BECAME WEDGED AND AS A RESULT, THE MICROCATHETER HAD DIFFICULTY ADVANCING BUT IT WAS EVENTUALLY PLACED WITH FORCE AT THE IIA. THE DELIVERY OF THE DELTAFILL18 18MM X 55CM (DLF181855 / S13470) WAS STARTED. FLUOROSCOPY WAS USED TO ENSURE THAT THE MARKER PASSES OVER THE HUB. THE COIL DELIVERY SYSTEM HAD DIFFICULTY AT THE LOCATION WHERE THE CONTRAST CATHETER BECAME WEDGED AND THE MICROCATHETER HAD DIFFICULTY WITH ADVANCEMENT WHEN IT WAS PASSING THROUGH. IT WAS NOT POSSIBLE TO DELIVER THE COIL AT THE TARGET SITE AS THE COIL CAME OUT AS ONE LOOP. STRONG RESISTANCE WAS FELT WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL FROM THE MICROCATHETER; THE COIL AND THE MICROCATHETER WERE REMOVED FROM THE PATIENT AS A UNIT. WHEN THE DELIVERY WIRE WAS WITHDRAWN, IT WAS CONFIRMED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7457259 ↗