DELTAFILL DLF100616Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704077107), received between May 19, 2020 and Oct 5, 2021 — classified as 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2021Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAFILL10 6MM X 16CM COIL (DLF100616, K10251) BECAME ¿STUCK¿ IN THE GREEN INTRODUCER. NEXT, THE GUIDE GETS OFF THE WHITE SLEEVE. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO SURGERY DELAY DUE TO THE REPORTED EVENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO MICROCATHETER WAS USED, THE COIL FAILED DURING INSPECTION, PRIOR TO BE INTRODUCED IN THE MICROCATHETER. THE INTRODUCER SLEEVE SEEMED TO BE DAMAGED (CRUSHED) RIGHT AFTER OPENING THE STERILE BAG. THE PLACE IS NEAR THE GREEN INTRODUCER. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE ANALYSIS OF THE PRODUCT RECEIVED, THE EMBOLIC COIL IS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576435 ↗
• MalfunctionJul 27, 2020Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, TWO DELTAFILL COILS (DLF100616, L11401 AND DLF100820, L11765) DIDN¿T DETACH PROPERLY. THERE WAS NO PATIENT INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED AT THE TIME OF REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10327197 ↗
• MalfunctionMay 19, 2020Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE EMBOLIZATION PROCEDURE TO TREAT A SYMPTOMATIC DURAL CAVERNOUS SINUS FISTULA, THE 6MM X 16CM DELTAFILL 10 COIL (DLF100616 / L13720) WAS DETACHED BEFORE IT WAS USED FOR THE PROCEDURE, WHEN THE PACKAGE WAS OPENED. IT WAS NOT CAUSED BY RESISTANCE BETWEEN THE COIL AND THE INTRODUCER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10073235 ↗