DELTAFILL DLF182260Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704077176), received between Aug 27, 2018 and Jun 12, 2026 — classified as 1 injury, 6 malfunctions.

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

• MalfunctionJun 12, 2026Material Rupture; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF A PULMONARY ARTERY TO TREAT A PULMONARY ARTERIOVENOUS FISTULA, THE 22MM X 60CM DELTAFILL 18 COIL (DLF182260 / 2232574S) WAS PREPARED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU). DURING USE, IT WAS REPORTED THAT RESISTANCE WAS FELT AT THE DISTAL TIP OF THE INTRODUCER. THE COIL DID NOT EXIT FROM THE TIP. WHEN THE DELIVERY WIRE WAS ADVANCED, THE COIL AND THE FLEXIBLE PORTION OF THE WIRE DEVIATED FROM THE SHEATH. THE COIL COULD NOT BE USED, AND IT WAS REPLACED WITH ANOTHER COIL OF THE SAME SIZE AND SPECIFICATIONS. TH PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE IMPACT ON THE PATIENT. CONTINUOUS FLUSH WAS MAINTAINED. THE ASSOCIATED MICROCATHETER USED WAS A LEONIS MOVA MICROCATHETER (SB-KAWASUMI LABORATORIES) THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE PRODUCT INVESTIGATION COMPLETED ON 12-JUN-2026. BASED ON THE COMPLETED PRODUCT INVESTIGATION, THIS EVENT HAS BEEN DETERMINED TO BE USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25493946 ↗
• MalfunctionJun 24, 2025Separation Failure; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A COIL EMBOLIZATION OF INTERNAL ILIAC ARTERY PRIOR TO URGENT STENT GRAFT IMPLANTATION TO TREAT ABDOMINAL AORTA ANEURYSM. AFTER APPROACHED TO THE INTERNAL ILIAC ARTERY WITH THE DIAGNOSTIC CATHETER AND THE COILING SUPPORT MICROCATHETER (MEDICOS HIRATA), THE DELTAFILL18 22MM X 60CM COIL (DLF182260, 0932402S) WAS THE FIRST COIL PLACED, THE PHYSICIAN CONNECTED THE CABLE AND ATTEMPTED TO DETACH THE COIL, BUT NO RESPONSE. THE COIL WAS RE-SHEATHED AND REPLACED WITH ANOTHER NEW COIL WITH THE SAME PRODUCT CODE. AFTER CHECKING THE ELECTRICAL CONTINUITY OF THE NEW COIL, IT WAS IMPLANTED. THEN, THE FIRST DELTAFILL18 COIL WAS CONNECTED AGAIN, BUT NO RESPONSE WAS OBSERVED. THE PHYSICIAN DETERMINED THAT THE COIL COULD NOT BE USED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318300 ↗
• MalfunctionJul 27, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A PERCUTANEOUS TRANSHEPATIC PORTAL EMBOLIZATION, A DELTAFILL18 22MM X 60CM COIL (DLF182260, 30927153) WAS USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DELTAFILL18 COULD NOT BE DETACHED, SO IT WAS RETRIEVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER NEW DELTAFILL18 COIL, WHICH WAS DETACHED WITHOUT ANY PROBLEMS. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS UNKNOWN. THE LESION WAS A PORTAL VEIN. OTHER CONCOMITANT DEVICE IS EXSELSIOR SL10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405815 ↗
• MalfunctionJun 27, 2023Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF SUPERIOR GLUTEAL ARTERY AND INFERIOR GLUTEAL ARTERY, A DELTAFILL18 22MM X 60CM COIL (DLF182260, 30927154) WAS USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS A RESISTANCE DURING DELIVERY, SO THE DELTAFILL18 COIL WAS RETRIEVED AND FOUND UNRAVELED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER NEW COIL. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17212109 ↗
• 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 13112382 ↗
• MalfunctionJan 7, 2020Stretched; Unraveled Material; Stretched; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE 22MM X 60CM DELTAFILL 18 COIL (DLF182260 / L15482) WAS USED WITH THE PROGREAT® ALPHA MICROCATHETER (TERUMO), HOWEVER, THERE WAS AN INTENSE RESISTANCE BETWEEN THE COIL AND THE CONCOMITANT MICROCATHETER. THE COIL COULD NOT ADVANCED. THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL, BUT THE COIL BECAME UNRAVELED. THE MICROCATHETER AND THE COIL WERE REMOVED TOGETHER AS A SYSTEM FROM THE PATIENT¿S ANATOMY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9558781 ↗
• MalfunctionAug 27, 2018Material Deformation; Material Deformation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-GRAFTING PROCEDURE FOR AN ENDOLEAK, THE DELTAFILL 18 22 MM X 60 CM (DLF182260 / S13115) WAS CHOSEN AS ONE OF THE COILS TO BE USED, BUT ITS SIZE DID NOT FIT THE LESION. WHEN THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL, THE ZIPPER BECAME STUCK WITH THE DEPLOYMENT SHEATH AND AS A RESULT, THE COIL COULD NOT BE RESHEATHED. THE DELTAFILL COIL WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE OR DELAY. A TOTAL OF 12 COILS WERE USED TO COMPLETE THE PROCEDURE. NO EXCESSIVE FORCE WAS USED DURING THE UN-SHEATHING AND RE-SHEATING OF THE COIL; THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. 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 PRODUCT WAS RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7820145 ↗