DELTAFILL DLF180935Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704077237), received between Sep 18, 2018 and Sep 13, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2023Break; Material Rupture; Positioning Problem; Break; Material Rupture; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT THE RENAL ARTERY ANEURYSM, A DELTAFILL18 9MM X 35CM COIL (DLF180935, 30464369) WAS ATTEMPTED TO BE RE-SHEATH BECAUSE THE COIL SIZE DID NOT FIT, BUT THE SHEATH GOT DAMAGED, AND IT WAS DIFFICULT TO RETRIEVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER NEW COIL. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. THE DELTAFILL WAS USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). OTHER CONCOMITANT DEVICE IS EXSELSIOR 1018 MICROCATHETER. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT IT WAS POOR CONFORMABILITY THAT LED TO THE RE-SHEATHING. THERE WAS NO NECK REMODELING UTILIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17739272 ↗
• MalfunctionFeb 13, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE WITH THE TARGET LOCATED AT THE SPLENIC ARTERY, THE FIRST COIL, A 6MM X 25CM DELTAFILL 18 COIL (DLF180625 / 30915597) WAS USED FOR INTRA-ANEURYSMAL PACKING AND ISOLATION ON THE DISTAL SIDE. A SECOND COIL, A 9MM X 35CM DELTAFILL 18 COIL (DLF180935 / 30797232) AS USED FOR INTRA-ANEURYSMAL PACKING. WHEN THE FIRST COIL WAS BEING DELIVERED, THE INTRODUCER SHEATH GOT DAMAGED AND COIL INSERTION WAS NOT POSSIBLE. THE SECOND COIL WAS UNABLE TO BE DETACHED DUE TO BREAKAGE. BOTH COILS WERE REPLACED WITH DIFFERENT SIZED COILS AND THE PROCEDURE RESUMED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. PER THE COMPLAINT, ONLY THE SECOND COIL, (DLF180935 / 30797232) IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16369090 ↗
• MalfunctionSep 18, 2018Material Deformation; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A 6MM DIAMETER SPLENIC ARTERY ANEURYSM, THE 9MM X 35CM DELTAFILL18 (DLF180935/S13318) THERMO-MECHANICAL COIL WAS INSERTED BUT THE SIZE DID NOT FIT; THEREFORE, IT WAS REMOVED BUT THE SHEATH BECAME DAMAGED. THE PROGREAT (TERUMO) MICROCATHETER WAS REPLACED WITH A DIFFERENT SIZE MICROCATHETER AND A COMPETITOR COIL WAS IMPLANTED IN THE ANEURYSM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO AND FOLLOWING THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. A CHIKAI12 (ASAHI INTECC) GUIDEWIRE, A 4F CONTRAST CATHETER, A PROGREAT (TERUMO) MICROCATHETER, AN ENPOWER CONTROL CABLE (ECB000182-00/S14342), AND A DCB2 DETACHMENT CONTROL BOX WERE ALSO USED FOR THE CASE. AN ISOLATION OF THE FEEDER AND THE DRAINER WAS MADE. THE APPROACH WAS MADE VIA THE RIGHT FEMORAL ARTERY WITH THE CO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7887533 ↗