DELTAFILL DLF100208Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704077022), received between Feb 3, 2020 and Feb 19, 2026 — classified as 4 injuries, 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 7 most recent of 7 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 PREMATURLY DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393049 ↗
• 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 (B)(6) 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 15759715 ↗
• 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 DELTAFILL 10 5MM X 15CM (DLF100515/30415692), A DELTAFILL10 5MM X 15CM (DLF100515/30379777), A GALAXY G3 4MM X 12CM (GLY120412/30522183), A DELTAFILL 10 2MM X 8CM (DLF100208/30418880), A DELTAFILL10 2MM X 8CM (DLF100208/30407127), TWO DELTAFILL 10 2MM X 8CM (DLF100

  Patient problems: Ruptured Aneurysm

  MAUDE report 15759711 ↗
• 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 (B)(6), 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 (B)(6) 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 (DLF100208/30536993), A

  Patient problems: Ruptured Aneurysm

  MAUDE report 15759699 ↗
• 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 (B)(6) 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 (B)(6) 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 (DLF100208/30536

  Patient problems: Ruptured Aneurysm

  MAUDE report 15759568 ↗
• MalfunctionAug 12, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, THE DELIVERY SYSTEM OF A 2MM X 8CM DELTAFILL10 COIL (DLF100208, L16295) IS CAUSING SOME CONCERNS, THE COIL DOES NOT FILL THE ANEURYSM AS WELL AS THE USER WAS HOPING. IT IS DIFFICULT TO POSITION. IT¿S EITHER PROTRUDING INTO A VESSEL OR IS DIFFICULT TO BE FULLY ADVANCED. THE USER REPORTED THAT SOMETIMES THEY CANNOT ADVANCE A COIL FULLY AND IT¿S NOT DUE TO SIZING, PERHAPS IT IS INDEED DUE TO THE DELIVERY SYSTEM. THE CATHETER KICK BACK IS VERY CONCERNING. THE SYSTEM, ESPECIALLY THE DELIVERY WIRE FEELS VERY STIFF. IT¿S REQUIRING SOME MANIPULATION. DEPLOYMENT OF COILS TAKES TOO LONG, AS THEY ARE NOT EASY TO HANDLE, WHICH PRESENTS A RISK OF CLOT FORMING. THERE WAS NO PATIENT INJURY REPORTED. IMAGING WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10395529 ↗
• MalfunctionFeb 3, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE WITH THE TARGET SITE ON THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE 2MM X 8CM DELTAFILL 10 COIL (DLF100208 / L16127) DID NOT DETACH IN THE TARGET SITE IN THE PATIENT. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER COIL; THE REPLACEMENT COIL WAS INSERTED AND IMPLANTED WITHOUT ANY ISSUE. IT WAS REPORTED THAT THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED, IT WAS ALSO STILL ATTACHED TO THE DELIVERY SYSTEM. IT WAS REPORTED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT PERFORMED. THE LOW BATTERY AND FAULT LIGHTS WERE NOT SEEN DURING THE CASE. THE GREEN SYSTEM READY LIGHT DID ILLUMINATE, AND THE AUDIBLE SIGNAL BEEP WAS HEARD DURING THE ATTEMPT TO DETACH THE COIL. THE SAME DETACHMENT CONTROL BOX AND CONNECTING CABLE WERE USED TO DETACH THE REPLACEMENT COIL AND COMPLETE THE PROCEDURE. THE REPORTED EVENT DID NOT CAUSE ANY PROCEDURAL DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9660187 ↗