DELTAFILL DLF181242Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886704077121), received between Sep 22, 2017 and Feb 23, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Fracture; Difficult to Advance

  DURING A COIL EMBOLIZATION PROCEDURE TARGETING THE INTERNAL ILIAC ARTERY TRUNK TO TREAT AN INTERNAL ILIAC ARTERY ANEURYSM, DEVICES WERE USED IN ACCORDANCE WITH THEIR RESPECTIVE INSTRUCTIONS FOR USE (IFUS). THE PROCEDURE WAS PERFORMED USING A 4FR ANGIOGRAPHIC CATHETER (UNSPECIFIED BRAND) AND A PROWLER SELECT PLUS STRAIGHT MICROCATHETER. AFTER EMBOLIZING THE SUPERIOR AND INFERIOR GLUTEAL ARTERIES WITH MICRUSFRAME AND DELTAFILL COILS, EMBOLIZATION OF THE MAIN TRUNK WAS PERFORMED. DURING THE ATTEMPT TO USE THE 12MM X 42CM DELTAFILL 18 (DLF181242 / 2612521S) AS THE FIRST COIL, RESISTANCE WAS FELT AT THE PROXIMAL PORTION INSIDE THE MICROCATHETER. THE PHYSICIAN MANAGED TO ADVANCE THE COIL, BUT THE RESISTANCE WAS STRONG AND THE DELIVERY WIRE BROKE AT A THIN SECTION. THE PHYSICIAN SPLIT THE SHEATH UP TO THE BROKEN SECTION AND ATTEMPTED TO ADVANCE THE COIL, BUT IT WAS DIFFICULT. THE 12MM X 42CM DELTAFILL 18 WAS RETRIEVED. ANOTHER COIL FROM A DIFFERENT LOT OF THE SAME SPECIFICATIONS WAS USED AND DELIVERY WAS COMPLETED WITHOUT ANY RESISTANCE. IT WAS REPORTED AFTER PLACING ONE COIL OF THE SAME SPECIFICATION, ANOTHER 12MM X 42CM DELTAFILL 18 (DLF181242) FROM THE SAME LOT (2612521S) WAS INSERTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415879 ↗
• MalfunctionJun 30, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION THAT WAS PART OF A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE, AFTER THE CONCOMITANT MICROCATHETER, A LEONIS MOVA MICROCATHETER (SUMIMOTO BAKELITE) WAS INSERTED INTO THE LESION, THE COMPLAINT COIL, A 12 MM X 42 CM DELTAFILL 18 (DLF181242 / 30915619) APPROACHED THE LESION FOR COIL EMBOLIZATION, IT COULD NOT BE DETACHED AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER COIL FROM ANOTHER LOT. A TOTAL OF EIGHT (8) DELTAFILL 18 COILS WERE USED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243717 ↗
• MalfunctionMar 20, 2023Material Rupture; Material Rupture

  THE HEALTHCARE PROFESSIONAL THAT DURING AN EMERGENCY THORACIC AORTIC STENT PLACEMENT AND SUBCLAVIAN ARTERY EMBOLIZATION PROCEDURE, THE SUBCLAVIAN ARTERY WAS EMBOLIZED AFTER STENT PLACEMENT. THE TARGET LESION WAS ON THE SUBCLAVIAN ARTERY. A PROWLER SELECT PLUS MICROCATHETER WAS USED AND THE COMPLAINT COIL, A 12MM X 42CM DELTAFILL 18 COIL (DLF181242 / 30915616) WAS USED AFTER A 13MM AZUR35 COIL (TERUMO INTERVENTIONAL SYSTEMS) WAS USED AS THE FRAMING COIL. WHEN THE COMPLAINT COIL WAS BEING DELIVERED, THE INTRODUCER SHEATH GOT TORN AND THE EMBOLIC COIL BECAME EXPOSED AND USING IT WAS NOT POSSIBLE. CONTINUOUS FLUSH WAS MAINTAINED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER 12MM X 42CM COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 10-MAR-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THAT AN ADEQUATE FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE AT ANY TIME DURING THE ADVANCEMENT OF THE COMPLAINT COIL THROUGH THE MICROCATHETER. THE COMPLAINT COIL WAS NOT POSITIONED AT A RELATIVELY SHARP ANGLE TO THE MICROCATHETER. THE CONCOMITANT MICROCATHETER WAS NOT REMOVED WHEN THE COIL WAS REPLACED. THE COMPLAIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576365 ↗
• MalfunctionMar 10, 2023Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE INTERNAL ILIAC ARTERY FOR PRE-STENT GRAFT, A DELTAFILL18 12MM X 42CM COIL (DLF181242, 30915618) WAS USED FOR THE MAIN VESSEL. THREE AZUR 35 COILS WERE USED FROM A GUIDING CATHETER (HIGH FLOW) AND A MICROCATHETER (PROGREAT) WAS INSERTED. THE DELTAFILL18 12MM X 42CM COIL WAS UNABLE TO ADVANCE DUE TO THE POSSIBILITY OF SEVERE TORTUOSITY THEREFORE, THE DELIVERY WIRE WAS REMOVED, AND THE PHYSICIAN NOTICED THAT THE COMPLAINT COIL GOT EARLY DETACHED. HOWEVER, THE COIL WAS NOT FOUND ON FLUOROSCOPY AND ANOTHER DELTAFILL18 12MM X 42CM WAS ATTEMPTED TO BE USED BUT IT WAS UNABLE TO ADVANCE BECAUSE THE COIL OF THE FIRST DELTAFILL18 12MM X 42CM WAS INSIDE THE MICROCATHETER (MC). THE COMPLAINT COILS WERE REMOVED TOGETHER WITH THE PROGREAT AND THE PROCEDURE COMPLETED WITH AZUR 35 COIL(S). A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION RECEIVED INDICATING THAT SINCE THE SECOND COIL BECAME STUCK IN THE MICROCATHETER, THE PHYSICIAN CONSIDERED THAT THE FIRST COIL WITH PREMATURE DETACHED WAS CLOGGED IN THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16523003 ↗
• MalfunctionApr 6, 2021Break; Break

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF AN INTERNAL CAROTID ANEURYSM, A CONCOMITANT MICROCATHETER (PHENOM 17, MEDTORNIC) WAS DELIVERED TO THE LESION AND COILING EMBOLIZATION STARTED. THE COMPLAINT COIL, A 12MM X 42CM DELTAFILL18 (DLF181242, 30466092) WAS PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU) AND INSERTED INTO THE PATIENT. IT WAS BEING DELIVERED TO THE LESION, HOWEVER, THERE WAS ¿DAMAGE TO THE COIL PART AND JUNCTION OF THE COIL PART¿. IT WAS NOTICED WHEN THE COMPLAINT COIL WAS PUSHED BACK AND FORTH. THEREFORE, IT WAS REMOVED TOGETHER WITH THE MICROCATHETER (MC). THE MC WAS REPLACED WITH ANOTHER MICROCATHETER. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COMPETITIVE COIL PRODUCT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11619756 ↗
• MalfunctionJul 19, 2019Unraveled Material; Premature Separation; Unraveled Material; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM WITH THE FOLLOWING DIMENSIONS: 15MM X 10MM X 12MM AT THE SPLENIC ARTERY, THE 12MM X 42CM DELTAFILL 18 COIL (DLF181242 / S13829) WAS CHOSEN AS THE FIFTH COIL TO BE PLACED. DELTAFILL 18 COIL WAS DELIVERED TO THE TARGET LESION BUT WITH 3CM REMAINING, THE COIL COULD NO LONGER BE INSERTED. THE PHYSICIAN ATTEMPTED TO PULL THE COIL BACK INTO THE MICROCATHETER TO REPOSITION THE MICROCATHETER, BUT THE COIL BECAME UNRAVELED AND PREMATURELY DETACHED IN THE MICROCATHETER. THE MICROCATHETER WAS REMOVED AND THE COIL WAS REPLACED. THE PROCEDURE WAS COMPLETED AFTER THE COIL REPLACEMENT. IT WAS REPORTED THAT THERE WERE NO KINKS IN THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE COIL BECOMING UNRAVELED; THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED, AND NO RESISTANCE AT ANY TIME DURING THE COIL ADVANCEMENT THROUGH THE MICROCATHETER. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. IT WAS REPORTED THAT THE PRODUCT IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809484 ↗
• MalfunctionJul 2, 2019Unraveled Material; Unraveled Material

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION, THERE WAS STRONG RESISTANCE FELT BETWEEN A MICROCATHETER AND TWO COILS. A DELTAFILL18 20MM X 60CM (DLF182060, L14332) AND A DELTAFILL18 12MM X 42CM ((DLF181242, L14321). THE PHYSICIAN ATTEMPTED TO REMOVE THE COMPLAINT COILS, HOWEVER, BOTH COILS GOT STUCK IN THE MIDDLE OF THE MICROCATHETER AND THEY UNRAVELED IN THE MICROCATHETER. AFTER THAT, THE MICROCATHETER WITH THE COMPLAINT COILS WERE REMOVED TOGETHER FROM THE PATIENT¿S BODY, AND THE COMPLAINT COILS WERE REMOVED FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED BY APPROACHING THE SAME MICROCATHETER AGAIN TO THE TARGET LESION AND NON-CERENOVUS COILS WERE ADVANCED SMOOTHLY IN THE MICROCATHETER WITHOUT GETTING STUCK. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICES. THE DEVICES WERE USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE. NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8753074 ↗
• MalfunctionJan 2, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE ATTEMPT WAS MADE TO DETACH THE 12MM X 42CM DELTAFILL 18 (DLF181242/L12453) COIL USING THE ENPOWER CONTROL CABLE (ECB00018200/L13631), BUT THE GREEN SYSTEM READY LIGHT ON THE CABLE WAS NOT ILLUMINATED. THE 12MM X 42CM DELTAFILL 18 COIL WAS REPLACED WITH ANOTHER COIL OF THE SAME SIZE AND THE SAME ISSUE OCCURRED, THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE. THE ENPOWER CONTROL CABLE WAS REPLACED, AND THE REPLACEMENT COIL WAS SUCCESSFULLY DETACHED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8210515 ↗
• MalfunctionJul 23, 2018Material Fragmentation; Material Fragmentation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT EVENT OCCURRED DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT A RECANALIZED INTERNAL CAROTID ARTERY PARACLINOID ANEURYSM. THE INITIAL TREATMENT WAS PERFORMED IN (B)(6) 2018, A NEUROFORM ATLAS COIL (STRYKER) WAS IMPLANTED. DURING THE RE-TREATMENT PROCEDURE, AFTER THE FIRST COIL WAS IMPLANTED AND THE DELIVERY WIRE WAS WITHDRAWN. IT WAS REPORTED THEN THAT THERE WAS SOME RESISTANCE EXPERIENCED AROUND THE Y-CONNECTOR AREA. THE DELTAFILL 18 12MMX 42CM COIL (DLF181242 / S13346) WAS THE SECOND COIL SELECTED; IT WAS INSERTED INTO THE MICROCATHETER, RESISTANCE WAS EXPERIENCED AT THE HUB AND THE COIL COULD NOT ADVANCE IN THE MICROCATHETER. THE PHYSICIAN VISUALLY INSPECTED THE HUB AND CONFIRMED THAT THERE WAS A FOREIGN MATERIAL IN THE HUB. THE DISTAL END OF THE DELTAFILL COIL WAS EXAMINED AND IT WAS DISCOVERED THAT THE DISTAL END OF THE DELIVERY WIRE HAD PEELED OFF AND BECAME SEPARATED; THE FOREIGN MATERIAL NOTED IN THE HUB BY THE PHYSICIAN WAS THE SEPARATED FRAGMENT OF THE DELIVERY WIRE AND THIS CAUSED A BLOCK IN THE MICROCATHETER AND IMPEDED THE COIL FROM FURTHER ADVANCING IN THE MICROCATHETER. THE PHYSICIAN COMMENTED THAT THE Y-CONNECTOR MIGHT HAVE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7712958 ↗
• InjuryJun 18, 2018Material Separation; Material Protrusion/Extrusion; Premature Separation; Material Separation; Material Protrusion/Extrusion; Premature Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A STENT-ASSISTED COIL EMBOLIZATION OF A 12X6MM ANTERIOR COMMUNICATING ARTERY (ACA) ANEURYSM, THE 12MM X 42CM DELTAFILL18 ((B)(4)) THERMO-MECHANICAL COIL WAS DETACHED FROM THE GUIDE IT WAS ATTACHED TO WHEN THE PHYSICIAN ATTEMPTED TO REWIND IT TO GET ITS POSITION INSIDE THE ANEURYSM. THEY BEGAN TO REWIND IT BY PULLING THE GUIDE OUTWARDS AND THEY WERE REWINDING APPROXIMATELY 20 CM FROM THE COIL AND AT THAT MOMENT THEY NOTICED THAT THE GUIDE WAS STILL COMING OUT AND THE COIL WAS NOT MOVING UNTIL THEY COMPLETELY REMOVED THE GUIDE. HALF OF THE COIL WAS INSIDE THE ANEURYSM AND HALF INSIDE THE NAVIEN CATHETER. THEY USED A SL-10 MICROCATHETER FROM STRYKER. WHEN THEY OBSERVED THAT THE COIL HAD DETACHED FROM THE GUIDE, THEY ALSO SAW THAT WITHIN THE NAVIEN CATHETER THERE WERE STRANDS DETACHED FROM THE GUIDE THAT IS ATTACHED TO THE COIL AND THE COIL. THEY HAD TO USE AN AMPLATZ LOOP SNARE TO REMOVE THE DETACHED "PADS". IN THE FIRST PASS, THEY EXTRACTED THE LOOSE STRANDS WITH GREAT DIFFICULTY AND IN THE SECOND PASS THE COIL. THEY BELIEVED THAT THEY MANAGED TO REMOVE ALL THE DETACHED PARTS. THEY PROCEEDED WITH THE CASE BY FILLING THE ANEURYSM WITH C

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7609481 ↗
• MalfunctionSep 22, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT WHEN UNPACKING THE DELTAFILL18 COIL (DLF181242/S12206), THE PHYSICIAN NOTICED THAT THE DARK GREEN PART OF THE SHEATH (RE-SHEATHING TOOL) WAS BROKEN. THE PHYSICIAN DECIDED TO USE THE DELTAFILL18 COIL (COMPLAINT PRODUCT). THE PHYSICIAN BELIEVED THAT THERE WAS NO RELATIONSHIP BETWEEN THIS SMALL PART AND THE GENERAL CONDITION OF THE COIL. AFTER DEPLOYING THE FIRST 4-6MM, THE PHYSICIAN NOTICED THAT HE NO LONGER HAD CONTROL OF THE COIL. THE PHYSICIAN DECIDED TO WITHDRAW EVERYTHING, INCLUDING THE MICROCATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6886483 ↗