DELTAFILL DLF100820Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704079378), received between Nov 22, 2019 and Apr 14, 2022 — classified as 6 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2022Material Separation; Material Separation

  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). THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115885 ↗
• MalfunctionAug 28, 2020Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED BY THE FIELD, THERE WAS A DEFECT OF SPIRE TRANSFER FROM SHEATH TO AN UNSPECIFIC MICROCATHETER WITH AN 8MMX20CM DELTAFILL10 COIL (DLF100820, L11444) AND AN 8MMX20CM DELTAFILL10 COIL (DLF100820, L10287). THERE WAS NO PATIENT INJURY REPORTED. BASED ON THE PRODUCT INVESTIGATION OF THE DELTAFILL10 8MMX20CM (DLF100820, L11444) RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED. ALSO, THE PRODUCT INVESTIGATION FOR THE SECOND DELTAFILL10 8MMX20CM (DLF100820, L10287, INDICATED THAT THE EMBOLIC COIL WAS FOUND KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10465645 ↗
• MalfunctionAug 28, 2020Stretched; Stretched

  AS REPORTED BY THE FIELD, THERE WAS A DEFECT OF SPIRE TRANSFER FROM SHEATH TO AN UNSPECIFIC MICROCATHETER WITH AN 8MMX20CM DELTAFILL10 COIL (DLF100820, L11444) AND AN 8MMX20CM DELTAFILL10 COIL (DLF100820, L10287). THERE WAS NO PATIENT INJURY REPORTED. BASED ON THE PRODUCT INVESTIGATION OF THE DELTAFILL10 8MMX20CM (DLF100820, L11444) RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED. ALSO, THE PRODUCT INVESTIGATION FOR THE SECOND DELTAFILL10 8MMX20CM (DLF100820, L10287, INDICATED THAT THE EMBOLIC COIL WAS FOUND KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10465636 ↗
• MalfunctionAug 25, 2020Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING THE USE OF A 8MMX20CM DELTAFILL10 COIL ( DLF100820, L11765), IT WAS IMPOSSIBLE TO PUSH THE SPIRE INTO ITS SHEATH WITH RUPTURE OF THE SHEATH. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE DELTAFILL10 8MMX20CM ((B)(4)) RECEIVED, THE EMBOLIC COIL WAS FOUND KINKED AND SLIGHTLY STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10448347 ↗
• MalfunctionJul 27, 2020Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, TWO DELTAFILL COILS (DLF100616, L11401 AND DLF100820, L11765) DIDN'T DETACH PROPERLY. THERE WAS NO PATIENT INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED AT THE TIME OF REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10327204 ↗
• MalfunctionNov 22, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE WITH THE TARGET ANEURYSM ON THE RIGHT MIDDLE CEREBRAL ARTERY, IT WAS REPORTED THE 8MM X 20CM DELTAFILL 10 COIL (DLF100820 / L12992) WAS HAVING ISSUE DURING THE ATTEMPT THAT WAS MADE TO DETACH THE COIL. THE MICROCATHETER (VIA®17(MICROVENTION-TERUMO)) AND MARKER WERE REPOSITIONED, AND THE ENPOWER® DCB 2 (DCB2000500 / LOT# UNK) AND ENPOWER® CONNECTING CABLE (CCB00015700 / L16026) WERE EXCHANGED TO ATTEMPT TO DETACH THE COIL. AFTER 20 MINUTES, THE COIL SUCCESSFULLY DETACHED USING THE ORIGINAL ENPOWER® DCB2 AND THE ENPOWER CONNECTING CABLE. IT WAS REPORTED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED ON THE ENPOWER DETACHMENT SYSTEM. THE DETACHMENT CONTROL BOX BATTERY WAS FULL. NO FAULT LIGHT WAS SEEN DURING THE CASE, UPON PRESSING THE POWER BUTTON, ALL THE LIGHTS ON THE ENPOWER DCB ILLUMINATED INCLUDING THE GREEN SYSTEM READY LIGHT. THE AUDIBLE SIGNAL BEEP WAS HEARD, AND ALL THE CONNECTIONS FIT PROPERLY WITHOUT APPLICATION OF EXCESSIFVE FORCE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT. THE REPORTED ISSUE DID ADD AN ADDITIONAL 20 MINUTES TO THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9364349 ↗