DELTAFILL DLF100510Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704077077), received between Sep 29, 2020 and Jun 28, 2021 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2021Failure to Advance; Positioning Problem; Failure to Advance; Positioning Problem

  A REPORT FROM THE FIELD INDICATED THAT DURING A COIL EMBOLIZATION OF A RUPTURED CEREBRAL ANEURYSM, A 5MM X 10CM DELTAFILL10 (DLF100510/30415691) COIL COULD NOT BE POSITIONED VERY WELL IN THE ANEURYSM AND WAS THEREFORE RESHEATHED. THE COIL WAS RESHEATHED WITHOUT INCIDENT AFTER SHORT CLEANING IN HEPARINIZED SODIUM CHLORIDE SOLUTION. WHEN INTRODUCING THE COIL AGAIN IN THE UNSPECIFIED MICROCATHETER, THE COIL COULD ONLY BE ADVANCED SLIGHTLY THROUGH THE FLUSHED MICROCATHETER. FULL INSERTION AND ADVANCEMENT OF THE COIL WITHIN THE MICROCATHETER WAS NOT POSSIBLE. DUE TO ACUTE BLEEDING OF THE ANEURYSM, THE COIL HAD TO BE RETRIEVED AND EXCHANGED FOR ANOTHER COIL. THE CONSEQUENT DELAY IN PROCEDURE REPORTEDLY WORSENED THE PATIENTS OUTCOME SINCE BLEEDING WAS ACUTE AND INTRACRANIAL HEMORRHAGE INCREASED. IT WAS FURTHER STATED THAT THE COIL EXCHANGE PROLONGED THE PROCEDURE AND THUS DECREASED CHANCES OF GOOD PATIENT OUTCOME. OTHER COILS HAD TO BE USED; THEREFORE, THERE WAS INCREASED X-RAY EXPOSURE TO THE PATIENT AND PHYSICIANS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT INITIATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12076856 ↗
• MalfunctionSep 29, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 5MM X 10CM DELTAFILL 10 COIL (DLF100510 / L11281) WAS THE THIRD OF THREE COILS THAT WAS CHOSEN TO BE USED AS THE FRAMING COIL OF THE PROCEDURE AFTER THE FIRST TWO COILS, TWO 5MM X 15CM DELTAFILL 10 COIL (DLF100515) FROM LOTS L14367 AND L13007 HAD ISSUES AND COULD NOT BE USED. THIS THIRD COIL ALSO FAILED TO DETACH. THE PHYSICIAN REPLACED THIS 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 10601228 ↗