DELTAFILL DLF100515Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704077084), received between Nov 6, 2017 and Nov 9, 2022 — 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 15759701 ↗
• 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)(4)), 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 (DLF100208/30

  Patient problems: Ruptured Aneurysm

  MAUDE report 15759689 ↗
• MalfunctionJul 23, 2021Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE TARGETING A GIANT BASILAR ARTERY ANEURYSM, AFTER THE PHYSICIAN HAD ALREADY SUCCESSFULLY PLACED SEVEN (7) DIFFERENT COILS USING THE 150CM X 50CM PROWLER 14 MICROCATHETER (606151FX / 30289569), WHILE TRYING TO FINALIZE COILING USING THE 9MM X 25CM DELTAFILL 10 COIL (DLF100925 / 30395326), THERE WAS RESISTANCE ENCOUNTERED DURING THE ADVANCEMENT ATTEMPT. THE PHYSICIAN REMOVED THE COIL AND MADE ANOTHER ATTEMPT TO ADVANCE THE COIL THE SMALLER COIL, A 5MM X 15CM DELTAFILL 10 (DLF100515 / 30452192). THE SAME RESISTANCE WAS ENCOUNTERED AND IT WAS REPORTED THAT THE COIL BECAME STUCK IN THE MICROCATHETER AND THE PHYSICIAN COULD NOT REMOVE THE COIL. HE DECIDED TO REMOVE THE COIL/MICROCATHETER SYSTEM OUT OF THE PATIENT; THE PHYSICIAN CHECKED THE DEVICE ON THE TABLE AND NOTED THAT THE PROWLER 14 MICROCATHETER HAS A HOLE IN IT; THERE WAS A VISIBLE KINK ON THE PROWLER 14 MICROCATHETER. CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. IT WAS REPORTED THAT THE 9MM X 25CM DELTAFILL 10 COIL THAT WAS REMOVED WAS NOT STRETCHED, IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THERE WAS NO BLOOD FLOW REDUCTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12220327 ↗
• MalfunctionSep 29, 2020Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 5MM X 15CM DELTAFILL 10 COIL (DLF100515 / L14367) WAS ONE OF THREE COILS CHOSEN TO BE USED AS THE FIRST FRAMING COIL OF THE PROCEDURE. THIS COIL COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN REMOVED THE COIL AND THE MICROCATHETER (UNKNOWN BRAND) AT THE SAME TIME. INSPECTION AFTER THE COIL AND MICROCATHETER WERE REMOVED REVEALED THAT THE COIL HAD BECOME STRETCHED. A SECOND 5MM X 15CM DELTAFILL 10 COIL (DLF100515 / L13007) WAS USED, BUT THIS COIL FAILED TO DETACH; THE AUDIBLE SIGNAL WAS HEARD BUT THE COIL DID NOT DETACH. A THIRD COIL, A 5MM X 10CM DELTAFILL 10 COIL (DLF100510 / L11281) WAS USED BUT IT ALSO FAILED TO DETACH. THE PHYSICIAN REPLACED THIS THIRD COIL WITH ANOTHER 5MM X 10CM DELTAFILL 10 COIL. THE FOURTH ATTEMPT WAS SUCCESSFUL, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10601259 ↗
• MalfunctionSep 29, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 5MM X 15CM DELTAFILL 10 COIL (DLF100515 / L13007) WAS THE SECOND COIL OF THREE COILS CHOSEN TO BE USED AS THE FRAMING COIL OF THE PROCEDURE AFTER THE FIRT COIL, A 5MM X 15CM DELTAFILL 10 COIL FROM LOT L14367 BECAME IMPEDED IN THE MICROCATHETER, AND THEN STRETCHED INSIDE THE MICROCATHETER WHEN IT WAS REMOVED. THE SECOND COIL FAILED TO DETACH; THE AUDIBLE SIGNAL WAS HEARD BUT THE COIL DID NOT DETACH. A THIRD COIL, A 5MM X 10CM DELTAFILL 10 COIL (DLF100510 / L11281) WAS USED, BUT IT ALSO FAILED TO DETACH. THE PHYSICIAN REPLACED THIS THIRD COIL WITH ANOTHER 5MM X 10CM DELTAFILL 10 COIL. THE FOURTH ATTEMPT WAS SUCCESSFUL, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10601239 ↗
• MalfunctionNov 6, 2017Kinked; Stretched; Kinked; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A DELTAFILL10 (DLF100515/ C41617) COIL COULD NOT BE UNSHEATHED AND PROTRUDED OUT OF THE SHEATH WHILE THE PHYSICIAN ATTEMPTED TO SLIDE THE INTRODUCER SHEATH BACK TO ADVANCE THE COIL. THE COIL WAS REMOVED FROM THE VALVE AND NOT USED. THE EVENT DID NOT RESULT IN PROCEDURE DELAY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7004984 ↗