DELTAFILL DLF100410Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704077053), received between Apr 4, 2024 and Oct 24, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2024Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TARGETING A LEFT POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM WITH NORMAL ANATOMY USING A CEREBASE (UNKNOWN CATALOG AND LOT NUMBER), A SOFIA¿ 6F INTERMEDIATE CATHETER (MICROVENTION) AND A TOTAL OF SIX COILS. IT WAS REPORTED THAT THREE OF THE SIX COILS ¿GOT STUCK IN THE MICROCATHETER AND COULD NOT BE REMOVED.¿ THE THREE COILS WERE: A 6MM X 25CM DELTAFILL 18 (DLF180625 / 30719513), A 5MM X 20CM DELTAFILL 18 (DLF180520 / 30942962), AND A 4MM X 10CM DELTAFILL 10 (DLF100410 / 30871956). IT WAS REPORTED THAT ¿WHEN TRYING TO PULL THE FIRST COIL [THE 6MM X 25CM DELTAFILL 18 (DLF180625 / 30719513)] OUT OF THE CONCOMITANT SL-10® MICROCATHETER (STRYKER), THE PUSHER WIRE TORE OFF AND THE COIL BECAME STUCK IN THE MICROCATHETER. THE MICROCATHETER THEREFORE, HAD TO BE REMOVED. IT WAS REPORTED THAT PRIOR TO THIS COIL, THE PREVIOUS THREE COILS ¿COULD BE PUSHED THROUGH THE SAME [MICROCATHETER].¿ THIS FIRST SL-10® MICROCATHETER (STRYKER) WAS NOT SAVED. THE SAME INCIDENT OCCURRED TWICE MORE DURING COIL EMBOLIZATION WITH THE 5MM X 20CM DELTAFILL 18 (DLF180520 / 30942962), AND A 4MM X 10CM DELTAFILL 10 (DLF100

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20526024 ↗
• MalfunctionApr 4, 2024Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PRE-OP PREPARATION FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT DEVICE, A 4MM X 10CM DELTAFILL 10 (DLF100410 / 30784433) COULD NOT BE PUSHED OUT OF THE INTRODUCER SHEATH. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 21-FEB-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE COIL HAS NOT YET BEEN INTRODUCED INTO THE MICROCATHETER. NO DAMAGE WAS VISIBLE ON THE DEVICE. NOTHING WAS NOTED TO BE OBSTRUCTING THE INTRODUCER. THE REPORTED ISSUE OCCURRED WHEN THE COIL WAS BEING INSPECTED IN SALINE; THE ISSUE OCCURRED BEFORE CONNECTING TO THE MICROCATHETER. EXCESSIVE FORCE HAD NOT BEEN EXERTED ON THE DEVICE. THE 4MM X 10CM DELTAFILL 10 WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 04-APR-2024, IN WHICH THE EMBOLIC COIL COMPONENT WAS OBSERVED TO BE STRETCHED AT THE PROXIMAL SECTION, THE REPORTED ISSUE MEETS USFDA REPORTING CRITERIA UNDER 21 CFR 803 AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19044790 ↗