DELTAFILL DLF100154Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704076957), received between Aug 19, 2019 and Nov 11, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (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.

• InjuryNov 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, THE (B)(6) FEMALE PATIENT WITH A HISTORY OF DIABETES, UNCONTROLLED HYPERTENSION, UNCONTROLLED HYPERLIPIDEMIA, HEADACHES, MIGRAINES, SLEEP APNEA, TUBAL LIGATION, ROSACEA, FATTY LIVER, (B)(6), BENIGN PAROXYSMAL VERTIGO, AND CLASS 2 OBESITY (BMI 37 KG/M2) UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF A RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM ON (B)(6) 2019. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED AN UNRUPTURED RIGHT MCA BIFURCATION ANEURYSM WITH THE FOLLOWING DIMENSION: HEIGHT 4.9MM, DOME 5.2MM, MAXIMUM ANEURYSM DIAMETER 5.6MM, NECK SIZE 3.2MM, AND DOME-TO-NECK RATIO 1.6MM. THE PARENT VESSEL DIAMETER WAS 1.5MM. THE PATIENT UNDERWENT COIL EMBOLIZATION WITH THE IMPLANTATION OF ONE 4MM X 11.5CM MICRUSFRAME 10 COIL (MFR100412 / L10083), ONE 3MM X 6CM GALAXY G3 COIL (GLY120306 / L12402), ONE 2.5MM X 5CM GALAXY G3 COIL (GLY122505 / L11547), ONE 1.5MM X 4CM DELTAFILL 10 COIL (DLF100154 / UNKNOWN LOT NUMBER), AND ONE 1.5MM X 1CM DELTAXSFT 10 COIL (DLXA100151 / UNKNOWN LOT NUMBER) VIA A HEADWAY DUO MICROCATHETER (MICROVENTION) MICROCATHETER. A NEUROFORM ATLAS® STENT SYSTEM (STRYKER) WAS IMPLANTED FOR NECK REMODELING. HEPARIN (7000 UNITS)

  Patient problems: Infarction, Cerebral; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10824563 ↗
• MalfunctionDec 17, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 5MM X 4CM DELTAFILL 10 COIL (DLF100154 / L11457) WAS NOT DETACHED IN THE ANEURYSM. THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT AND ATTEMPTED TO DETACH IT TO FIND OUT THE CAUSE FOR THE FAILURE TO DETACH WHILE IN THE ANEURYSM. THE COIL DID BECOME DETACHED OUTSIDE THE PATIENT. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9482170 ↗
• MalfunctionAug 19, 2019Positioning Problem; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, THE PHYSICIAN DIDN'T LIKE THE SHAPE OF A 1.5MM X 4CM DELTAFILL COIL (DLF100154, L11298) DEPLOYMENT AND DECIDED TO PULL IT OUT. DURING RESHEATHING OF THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. THE COMPLAINT PRODUCT WAS THE SECOND COIL TO BE USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8907049 ↗