DELTAFILL DLF100720Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704079408), received between Nov 6, 2017 and Oct 18, 2021 — classified as 3 malfunctions.

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

• MalfunctionOct 18, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAFILL10 7MMX20CM COIL (DLF100720, L14263) WAS BEING USED AS A FIRST COIL. THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNSPECIFIED MICROCATHETER (MC) AT THE SAME TIME. AFTER INSPECTION, IT TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647505 ↗
• MalfunctionJan 28, 2021Material Separation; Migration; Material Separation; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE (B)(6) MALE PATIENT PRESENTED WITH A RIGHT LATERAL WIDE NECK BASILAR ANEURYSM WITH SUBARACHNOID HEMORRHAGE UNDERWENT THE ENDOVASCULAR EMBOLIZATION PROCEDURE. A BALLOON CATHETER, MICROCATHETER AND A 7F CATHETER WERE USED WITH THE 7MM X 20CM DELTAFILL 10 COIL (DLF100720 / L14263). WHEN THEY DRAINED OFF THE BALLOON CATHETER, THE COIL ¿STARTED TO FALL OUT.¿ THE PHYSICIAN WANTED TO REMOVE THE COIL AND IT WAS THE FIRST ATTEMPT WHEN THE COIL BROKE INTO TWO PIECES. THE PHYSICIAN WAS ABLE TO CATCH THE SMALLER PIECE WITH THE BALLOON CATHETER AND THE OTHER PIECE TOGETHER WITH THE MICROCATHETER. THE REPORTED EVENT RESULTED IN A 10-MINUTE PROCEDURE DELAY. THERE WAS NO ADVERSE EVENT OR COMPLICATION TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11248351 ↗
• MalfunctionNov 6, 2017Kinked; Stretched; Physical Resistance; Kinked; Stretched; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, WHILE USING A DELTAFILL10 (DLF100720/S11190), THERE WAS RESISTANCE BETWEEN THE COIL AND INTRODUCER DURING ADVANCEMENT OF THE COIL INTO THE PROWLER LPS (606S155MX/LOT UNK) AND THE COIL WAS FOUND TO BE DAMAGED DURING PRODUCT ANALYSIS. THE COIL WAS FLUSHED PER PROTOCOL AND PLACED INTO HEMOSTATIC VALVE. AS THE DOCTOR BEGAN TO PUSH THE COIL INTO THE INTRODUCER/MICROCATHETER HE ENCOUNTERED RESISTANCE. HE PULLED BACK THE SYSTEM, REINTRODUCED INTO HEMOSTATIC VALVE AND ATTEMPTED TO ADVANCE THE COIL AGAIN GETTING THE SAME RESISTANCE. THE COIL WAS REMOVED FROM THE VALVE AND NOT USED. THE DELTAFILL DID NOT APPEAR DAMAGED. THE PROCEDURE WAS NOT DELAYED AND WAS SUCCESSFULLY COMPLETED USING THE SAME MICROCATHETER. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7004844 ↗