DELTAFILL DLF100308Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704077046), received between Mar 2, 2018 and Feb 19, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Failure to Advance

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, TWO DELTAFILL10 2MM X 8CM COILS (PRODUCT CODES: DLF100208, LOT NUMBERS: 2232554S AND 2232541S) AND A DELTAXSFT10 2MM X 4CM COIL (PRODUCT CODE: DLX100204, LOT NUMBER: 2022553S) COULD NOT BE INSERTED INTO THE ECHELON10, MEDTRONIC MICROCATHETER (MC). ADDITIONAL EVENT INFORMATION INDICATED THAT ANOTHER DELATAFILL AND DELTAXSFT COILS WERE SUCCESSFULLY USED WITH THE MICROCATHETER. THERE WAS NO NEED TO REMOVE OR REPLACE THE MICROCATHETER DURING THE PROCEDURE. THE TARGET VESSEL WAS THE MIDDLE CEREBRAL ARTERY (MCA), AND SPECIFIC ANATOMICAL CHARACTERISTICS¿INCLUDING CALCIFICATION, TORTUOSITY, AND VESSEL DIAMETER¿WERE NOT AVAILABLE. THROUGHOUT THE INTERVENTION, THERE WERE NO OBSERVATIONS OF PHYSICAL DAMAGE TO THE DEVICES, AND NO OBSTRUCTIONS WITHIN THE MICROCATHETER WERE NOTED. A CONTINUOUS FLUSH WAS MAINTAINED FOR THE DURATION OF THE PROCEDURE. BASED ON THE PRODUCT ANALYSIS OF THE RETURNED DEVICE, THE EMBOLIC STENT WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24392938 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 67-YEAR-OLD MALE PATIENT (SUBJECT 00971-020), WITH A MEDICAL HISTORY OF CONTROLLED HYPERLIPIDEMIA, CLASS 1 OBESITY (BMI OF 30 TO < 35), CONTROLLED HYPERTENSION AND BEING A CURRENT SMOKER UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED MIDLINE BASILAR ARTERY ANEURYSM ON 15-MAR-2022. MODIFIED RANKING SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 13MM, DOME 15MM, MAXIMUM ANEURYSM DIAMETER 15MM, NECK SIZE 8.5MM, AND THE DOME-TO-NECK RATIO OF 1.8MM. THE PARENT VESSEL DIAMETER WAS 4.1MM. COIL EMBOLIZATION WAS PERFORMED USING THE FOLLOWING EIGHT (8) CERENOVUS COILS: TWO (2) GALAXY G3 8MM X 24CM (GLY120824/K10393), A GALAXY G3 6MM X 20CM (GLY120620/30490147), A GALAXY G3 6MM X 20CM (GLY120620/ K10607), TWO (2) GALAXY G3 5MM X 15CM (GLY120515/30357953), A GALAXY G3 5MM X 15CM (GLY120515/30422339), A DELTAFILL10 5MM X 15CM (DLF100515/30415692), A DELTAFILL10 5MM X 15CM (DLF100515/30379777), A GALAXY G3 4MM X 12CM (GLY120412/30522183), A DELTAFILL10 2MM X 8CM (DLF100208/30418880), A DELTAFILL10 2MM X 8CM (DLF100208/30407127), TWO DELTAFILL10 2MM X 8CM (DLF100208

  Patient problems: Ruptured Aneurysm

  MAUDE report 15759734 ↗
• MalfunctionNov 21, 2018Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, SEVERAL ATTEMPTS WERE MADE TO DETACH THE DELTAFILL 10 3MM X 8CM COIL (DLF100308 / LOT# NOT AVAILABLE) BUT THE COIL DID NOT DETACH; IT WAS ALSO REPORTED THAT DURING THE ATTEMPT TO DETACH THE COIL, MOVEMENT WAS CREATED IN THE MICROCATHETER. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8097571 ↗
• MalfunctionMar 2, 2018Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  A REPORT WAS RECEIVED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION OF A 10MM CORONARY ARTERY ANEURYSM, AFTER SIX COMPETITOR COILS WERE PLACED, THE 3MM X 8 CM DELTAFILL10 (DLF100308/S11154) THERMO-MECHANICAL COIL WAS SELECTED AS SEVENTH; HOWEVER, THERE WAS A COMPARTMENT AT THE NECK SIDE OF THE ANEURYSM (AT 3 O-CLOCK) AND IT WAS DECIDED THAT THE COIL SHAPE WAS NOT FIT FOR THE LESION AND COULD NOT BE PLACED IN THE ANEURYSM. THE COIL WAS REPLACED WITH A COMPETITOR COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE OR DELAY. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PATIENT¿S LEVEL OF VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTEDLY UNKNOWN. A 0.014 190CM SION BLACK (ASAHI INTECC) GUIDEWIRE, A 7F 100CM HYPERION GUIDING CATHETER, A PROWLER SELECT LPES (606-S155FX/1773576) MICROCATHETER, AN ENPOWER (ECB000182-00/S13940) CONTROL CABLE, AN 3.5 X 8 XIENCE XPEDITION (ABBOTT VASCULAR) STENT, AND SIX (6) IDC (BOSTON SCIENTIFIC) COILS WERE ALSO USED IN THE CASE. COIL EMBOLIZATION WAS INITIATED FOLLOWING STENT PLACEMENT. SIX IDC (BOSTON SCIENTIFIC) COILS WERE PLACED PRIOR TO THIS COIL. THE COMPLAINT COIL WAS SELECTED FOR USE AS FINISHING COIL. THE COMP

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7309045 ↗