DELTAFILL DLF100612Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704077091), received between Dec 11, 2017 and Mar 1, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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.

• MalfunctionMar 1, 2022Material Rupture; Material Rupture

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAFILL 10 6MM X 12CM COIL (DLF100612, 30474387) WAS CHECKED AS USUAL, AND NOTHING CONSPICUOUS WAS FOUND. WHEN TRYING TO PULL THE COIL BACK INTO THE SYSTEM, A DEFECT WAS FOUND IN THE RE-SHEETING SYSTEM. SINCE THE WIRE OF THE COIL WAS NOW OUTSIDE THE SYSTEM EXTRALUMINALLY, IT WAS NO LONGER POSSIBLE TO PULL THE COIL BACK INTO THE SYSTEM AND THUS TO USE IT. THERE WAS SURGERY DELAY BY 10 MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGING. THERE WAS NO EXCESSIVE FORCE APPLIED. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND TO BE STRETCHED AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636992 ↗
• MalfunctionDec 11, 2017Stretched; 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 7105566 ↗