DELTAFILL DLF100925Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704079385), received between Dec 11, 2017 and Jun 24, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Stretched” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2022Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED DURING AN EMBOLIZATION OF A FISTULA IN THE ASCENDING AORTA AND THE RIGHT PULMONARY ARTERY, THE 8MM X 20CM DELTAFILL 10 (DLF100820 / 30452193) WAS CORRECTLY PURGED AND INSERTED INTO A PROWLER 14 MICROCATHETER (606151FX / 30289569). AN ATTEMPT WAS MADE TO RECOVER THE DEVICE WITH THE RESHEATHING TOOL, BUT DURING THE USE OF THE RESHEATHING TOOL, THE HYPOTUBE BROKE WITH NO WAY OF BEING ABLE TO RECOVER THE COIL. NO VISIBLE KINKS NOR OTHER DAMAGES WERE NOTED ON THE MICROCATHETER. THERE WAS NO RESISTANCE EXPERIENCED WHEN THE GUIDEWIRE WAS BEING ADVANCED THROUGH THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER (40 ML/HR). ADDITIONAL INFORMATION INDICATED THAT THE HYPOTUBE DID SPLIT INTO TWO PIECES. NO MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE DAMAGED HYPOTUBE. ANOTHER PROWLER 14 MICROCATHETER FROM THE SAME LOT WAS USED WITH THE REPLACEMENT COIL, A 5MM X 15CM DELTAFILL (DLF100515 / 30481255). DURING THE SAME PROCEDURE, ANOTHER COIL, A 7MM X 21CM GALAXY G3 (GLY120721 / 30537009) WAS CORRECTLY PURGED AND INSERTED INTO A PROWLER 14 MICROCATHETER (606151FX / 30289569). AN ATTEMPT WAS MADE TO RECOVER THE DEVICE WITH THE RESH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14809364 ↗
• MalfunctionOct 27, 2021Difficult 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 150 CM X 50 CM PROWLER 14 MICROCATHETER (606151FX / 30289569), WHILE TRYING TO FINALIZE COILING USING THE 9 MM X 25 CM 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 5 MM X 15 CM 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 9 MM X 25 CM DELTAFILL 10 COIL THAT WAS REMOVED WAS NOT STRETCHED, IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THERE WAS NO BLOOD FLOW R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708347 ↗
• MalfunctionAug 30, 2018Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A DELTAFILL COIL (DLF100925/L10288) WAS USED DURING AN ANEURYSM EMBOLIZATION PROCEDURE WHEN THE COIL PROTRUDED THROUGH THE INTRODUCER AND GOT STUCK WHILE LOADING THE COIL INTO THE MICROCATHETER. THE COIL WAS UNABLE TO BE PUSHED FURTHER INTO THE MICROCATHETER SO IT WAS REMOVED AND REPLACED WITH ANOTHER ONE. A 0.014" MICROCATHETER WAS USED DURING THIS PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE DEVICE PRIOR TO THE PROCEDURE. THE DEVICE WAS PREPPED AND USED ACCORDING TO THE IFU. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER AT ALL TIMES. THE PROCEDURE WAS DELAYED LESS THAN 30 MINUTES. NOTE: THIS EVENT WAS DEEMED MDR REPORTABLE BASED ON DEVICE EVALUATION FINDINGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7833493 ↗
• MalfunctionDec 12, 2017Stretched; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A PROCEDURE THREE DELTAFILL10 (DLF100925/S12152 X2 AND DLF100612/UNKNOWN LOT) WERE ATTEMPTED TO BE INTRODUCED THROUGH THE PROWLER SELECT LP MICROCATHETER (606-S155MX/17536302) BUT COULD NOT PASS THROUGH DESPITE BEING FLUSHED PRIOR TO USE. COMPETITOR PRODUCTS WERE FIRST USED WITH THE PROWLER SELECT LP MICROCATHETER, FOLLOWED BY SOME DELTAFILL18 COILS, AND NO ISSUES WERE EXPERIENCED. A TOTAL OF 8 COILS WERE IMPLANTED PRIOR TO THE COMPLAINT COILS. THE PHYSICIAN EXPERIENCED FRICTION, SIMILAR TO THE FRICTION EXPERIENCED WITH THE PREVIOUS GENERATION PRODUCT. THE PHYSICIAN FURTHER STATED THAT THE SHEATH IS MORE FRAGILE THAN THE ONE ON THE PREVIOUS GENERATION COILS AND PEELS MORE. THE PHYSICIAN REMOVED THE DELTAFILL10 COILS (COMPLAINT PRODUCTS) AND COMPLETED THE PROCEDURE WITH 18 MM COILS. THE FIRST 9 MM COIL WAS IMPOSSIBLE TO ADVANCE THROUGH THE HUB OF THE MICROCATHETER; SEVERE FRICTION WAS FELT. THE PHYSICIAN TRIED A SECOND ONE OF THE SAME DIAMETER AND THEN A THIRD COIL THAT WAS 6 MM IN DIAMETER; ALL HAD THE SAME ISSUE. THE PHYSICIAN REPORTED THAT THE COILS COULD NOT BE ADVANCED MORE THAN A FEW CENTIMETERS IN THE MICROCATHETER. THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7107670 ↗
• MalfunctionDec 11, 2017Kinked; Stretched; Kinked; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A PROCEDURE THREE DELTAFILL10 (DLF100925/S12152 X2 & DLF100612/UNKNOWN LOT) WERE ATTEMPTED TO BE INTRODUCED THROUGH THE PROWLER SELECT LP MICROCATHETER (606-S155MX/17536302) BUT COULD NOT PASS THROUGH DESPITE BEING FLUSHED PRIOR TO USE. COMPETITOR PRODUCTS WERE FIRST USED WITH THE PROWLER SELECT LP MICROCATHETER, FOLLOWED BY SOME DELTAFILL18 COILS, AND NO ISSUES WERE EXPERIENCED. A TOTAL OF 8 COILS WERE IMPLANTED PRIOR TO THE COMPLAINT COILS. THE PHYSICIAN EXPERIENCED FRICTION, SIMILAR TO THE FRICTION EXPERIENCED WITH THE PREVIOUS GENERATION PRODUCT. THE PHYSICIAN FURTHER STATED THAT THE SHEATH IS MORE FRAGILE THAN THE ONE ON THE PREVIOUS GENERATION COILS AND PEELS MORE. THE PHYSICIAN REMOVED THE DELTAFILL10 COILS (COMPLAINT PRODUCTS) AND COMPLETED THE PROCEDURE WITH 18MM COILS. THE FIRST 9MM COIL WAS IMPOSSIBLE TO ADVANCE THROUGH THE HUB OF THE MICROCATHETER; SEVERE FRICTION WAS FELT. THE PHYSICIAN TRIED A SECOND ONE OF THE SAME DIAMETER AND THEN A THIRD COIL THAT WAS 6MM IN DIAMETER; ALL HAD THE SAME ISSUE. THE PHYSICIAN REPORTED THAT THE COILS COULD NOT BE ADVANCED MORE THAN A FEW CENTIMETERS IN THE MICROCATHETER. THERE WE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7105399 ↗