DELTAFILL DLF181445Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704077138), received between Jun 20, 2018 and Sep 7, 2021 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2021Material Rupture; Positioning Problem; Material Rupture; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TARGETING AN ABDOMINAL GASTROINTESTINAL BLEED, THE 14MM X 45CM DELTAFILL 18 COIL (DLF181445 / L16553) WAS USED AS THE FIRST COIL. IT WAS RESHEATHED ONCE BECAUSE THE POSITION OF THE CONCOMITANT MICROCATHETER WAS NOT PROPER. HOWEVER, THE SHEATH DID NOT COVER THE WIRE PROPERLY AND AS A RESULT, THE COIL COULD NOT BE RESHEATHED. IT WAS REPLACED WITH ANOTHER 14MM X 45CM DELTAFILL 18 COIL (DLF181445) AND THE REPLACEMENT PERFORMED WITHOUT ANY ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH FOUR DELTAFILL 18 COILS. IT WAS REPORTED THAT THERE WAS NO RESISTANCE AT ANY TIME DURING THE ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER. THE COMPLAINT COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WAS NO BLOOD FLOW RESTRICTION / REDUCTION AS A RESULT OF THE EVENT. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED ISSUE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE MICROSCOPIC INSPECTIONS OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED PROTRUDING FROM THE INTRODUCER AND IN STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS ON 06 SEPTEMBER 2021, THIS EVEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12435948 ↗
• MalfunctionApr 29, 2021Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION AT THE INTERNAL ILIAC ARTERY AFTER A THORACIC ENDOVASCULAR AORTIC REPAIR (TVER) STENT GRAFTING, AN UNSPECIFIED MICROCATHETER (MC) WAS DELIVERED TO THE TARGET LESION AT THE SUBCLAVIAN ARTERY. TWO MICRUSFRAME COILS (UNKNOWN PRODUCT/LOT NUMBER) WERE ABLE TO BE ADVANCED THROUGH THE MC WITHOUT ANY PROBLEMS AND IMPLANTED. A 14MM X 45CM DELTAFILL18 COIL (DLF181445, L13550) WAS USED, BUT IT GOT KINKED IN THE CATHETER AFTER DELIVERY. THEREFORE, IT WAS REMOVED AND A 14MM X 45CM DELTAFILL18 (DLF181445, L13466) WAS USED, BUT IT BECAME UNRAVELED DURING ADVANCEMENT THROUGH THE SAME MICROCATHETER. IT WAS REPLACED WITH ANOTHER COIL (DIFFERENT LOT NUMBER). ALSO, THE WIRE OF A 16MM X 50CM DELTAFILL18 COIL (DLF181650, L13380) WAS BENT DURING DELIVERY AND NOT ABLE TO BE DELIVERED. IT WAS REPLACED WITH ANOTHER COIL (DIFFERENT LOT NUMBER). THE PROCEDURE COMPLETED SAFELY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO EXCESSIVE FORCE WAS USED AT ANY TIME WITH THE DEVICES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11745283 ↗
• MalfunctionApr 29, 2021Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION AT THE INTERNAL ILIAC ARTERY AFTER A THORACIC ENDOVASCULAR AORTIC REPAIR (TVER) STENT GRAFTING, AN UNSPECIFIED MICROCATHETER (MC) WAS DELIVERED TO THE TARGET LESION AT THE SUBCLAVIAN ARTERY. TWO MICRUSFRAME COILS (UNKNOWN PRODUCT/LOT NUMBER) WERE ABLE TO BE ADVANCED THROUGH THE MC WITHOUT ANY PROBLEMS AND IMPLANTED. A 14MM X 45CM DELTAFILL18 COIL (DLF181445, L13550) WAS USED, BUT IT GOT KINKED IN THE CATHETER AFTER DELIVERY. THEREFORE, IT WAS REMOVED AND A 14MM X 45CM DELTAFILL18 (DLF181445, L13466) WAS USED, BUT IT BECAME UNRAVELED DURING ADVANCEMENT THROUGH THE SAME MICROCATHETER. IT WAS REPLACED WITH ANOTHER COIL (DIFFERENT LOT NUMBER). ALSO, THE WIRE OF A 16MM X 50CM DELTAFILL18 COIL (DLF181650, L13380) WAS BENT DURING DELIVERY AND NOT ABLE TO BE DELIVERED. IT WAS REPLACED WITH ANOTHER COIL (DIFFERENT LOT NUMBER). THE PROCEDURE COMPLETED SAFELY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO EXCESSIVE FORCE WAS USED AT ANY TIME WITH THE DEVICES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11745279 ↗
• MalfunctionAug 28, 2018Stretched; Material Deformation; Stretched; Material Deformation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE AT THE INTERNAL ILIAC ARTERY (IIA), AFTER THE MICRUSFRAME 18 11MM X 18.9CM COIL WAS USED AS ANCHORING, THE DELTAFILL 18 14MM X 45CM COIL (DLF181445 / S13314) WAS THE SECOND COIL USED. IT WAS INSERTED INTO THE MICROCATHETER (UNKNOWN BRAND) AND BECAME STUCK IN THE MICROCATHETER. THE DELTAFILL 18 COIL AND THE MICROCATHETER WERE REMOVED AND REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE 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. THE PRODUCT WAS RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7822938 ↗
• MalfunctionJun 20, 2018Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM AT THE RENAL ARTERY, THE BALLOON CATHETER AND THE MICROCATHETER WERE INSERTED INTO THE GUIDE CATHETER; THE THREE DEVICES WERE INSERTED FROM THE LEFT FEMORAL ARTERY (FA) TO APPROACH THE TARGET SITE AS A UNIT. AFTER THE HERNIATION WAS PERFORMED WITH THE BALLOON CATHETER, THE COIL EMBOLIZATION PROCEDURE BEGAN. THE FIRST COIL WAS SELECTED, A STRYKER TARGET XXL 22 MM COIL WAS PLACED FOLLOWED BY 4 OTHER COILS PLACED. THREE DELTAFILL 20 MM COILS WERE PLACED AND THE PIOLAX C-STOPPER COIL WAS USED AS THE FILLING COIL. THE DELTAFILL18 14 MM X 45 CM COIL (DLF181445 / S13314) WAS THE COIL SELECTED FOR PLACEMENT NEAR THE ANEURYSM NECK. THE DELTAFILL18 COIL WAS INSERTED INTO THE MICROCATHETER (STRYKER, SL-10) BUT THE COIL ENCOUNTERED RESISTANCE. WHEN THE PHYSICIAN ATTEMPTED TO WITHDRAW THE COIL, IT BECAME UNRAVELED IN THE MICROCATHETER. THE DELTAFILL18 COIL WAS REMOVED ALONG WITH THE MICROCATHETER. THE DELTAFILL18 COIL WAS REPLACED WITH ANOTHER COIL (TARGET XXL). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7623488 ↗