DELTAFILL DLF100408Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704077060), received between Jul 30, 2018 and Jun 29, 2021 — classified as 2 injuries, 1 malfunction.

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

• InjuryJun 29, 2021Material Separation; Failure to Advance; Material Twisted/Bent; Material Separation; Failure to Advance; Material Twisted/Bent

  A REPORT FROM THE FIELD INDICATED THAT DURING A COIL EMBOLIZATION OF A RUPTURED CEREBRAL ANEURYSM, A 4MM X 8CM DELTAFILL10 (DLF100408/L16128) COIL COULD ONLY BE INTRODUCED INTO THE UNSPECIFIED MICROCATHETER ¿A LITTLE BIT¿. THEN, THE COIL WAS PULLED BACK A LITTLE AND READVANCED. DURING READVANCEMENT, THE RE-SHEATHING TOOL DETACHED DISTALLY FROM THE GREEN INSERTION TOOL. THUS, THE DEVICE POSITIONING UNIT (DPU) WIRE FORMED A LOOP WITHIN THE WHITE PROTECTIVE COIL SHEATH. THE PATIENT WAS ACUTELY BLEEDING, SO THE PHYSICIAN RETRIEVED THE COIL QUICKLY AND CHANGED FOR ANOTHER ONE. THE OTHER COILS WERE SUCCESSFULLY ADVANCED THROUGH THE MICROCATHETER TO COMPLETE THE PROCEDURE. THE CONSEQUENT DELAY IN PROCEDURE REPORTEDLY WORSENED THE PATIENT¿S OUTCOME SINCE BLEEDING WAS ACUTE AND INTRACRANIAL HEMORRHAGE INCREASED. IT WAS FURTHER STATED THAT THE COIL EXCHANGE PROLONGED THE PROCEDURE AND THUS DECREASED CHANCES OF GOOD PATIENT OUTCOME. OTHER COILS HAD TO BE USED; THEREFORE, THERE WAS INCREASED X-RAY EXPOSURE TO THE PATIENT AND PHYSICIANS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. THE COMPLAINT COIL WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COM

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12084568 ↗
• MalfunctionNov 28, 2018Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF A BLEEDING ANEURYSM POST PANCREATODUODENECTOMY PROCEDURE WHEN THE BLEEDING FROM THE GASTRODUODENAL ARTERY (GDA) STUMP OF THE COMMON HEPATIC ARTERY WAS CONFIRMED, THE MICROCATHETER (EXCELSIOR® 1018, STRYKER) APPROACHED THE TARGET LESION AND THE DELTAFILL 10 4MM X 8CM COIL (DLF100408 / S12436) WAS INSERTED AS THE ANCHORING COIL. THE MICROCATHETER KICKED BACK AND THE COIL WAS RE-SHEATHED. WHEN THE MICROCATHETER REACHED THE DISTAL PORTION, THE COIL WAS REINSERTED INTO THE MICROCATHETER, BUT THE COIL INTRODUCER SHEATH SPLIT OPENED AND THE COIL PROTRUDED FROM THE INTRODUCER SHEATH. THE DELTAFILL 10 COIL WAS REPLACED AND THE PROCEDURE CONTINUED TO SUCCESSFUL COMPLETION WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. IT WAS REPOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8112004 ↗
• InjuryJul 30, 2018Separation Failure; Malposition of Device; Separation Failure; Malposition of Device

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ANEURYSM TREATMENT ON THE MALE PATIENT, THE PHYSICIAN WANTED TO PLACE 10 COILS INTO THE ANEURYSM. THE 8TH COIL, A DELTAFILL 10 4MM X 8CM COIL (DLF100408 / L10338) COULD NOT BE COMPLETELY DETACHED. WHEN THE GUIDEWIRE WAS RETRACTED, THE COIL WAS ALSO DRAGGED FROM ITS PLACE. THE SURGEON MOVED THE GUIDEWIRE BACK AND FORTH AND WAS ABLE TO DETACH THE COIL BUT THE COIL DID NOT DETACH IN THE PROPER PLACE. THE PHYSICIAN USED A BALLOON (STRYKER TRANSFORM BALLOON) TO PLACE THE COIL INTO THE CORRECT LOCATION. IN USING THE BALLOON TO CORRECT THE COIL LOCATION, THE T1 VESSEL WAS INJURED WITH THE BALLOON WIRE AND THE PATIENT SUFFERED A SUBARACHNOID HEMORRHAGE. THE PATIENT WAS REPORTED TO HAVE MOVEMENT DISORDER AND DOUBLE VISION.

  Patient problems: Hemorrhage, Subarachnoid; No Consequences Or Impact To Patient

  MAUDE report 7733217 ↗