i-ED COIL 373-040815Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04540778177635), received between Oct 7, 2020 and Jan 18, 2024 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionJan 18, 2024Fracture; Fracture

  BALLOON ASSISTED COIL EMBOLIZATION OF AN LEFT ICA (INTERNAL CAROTID ARTERY) ANEURYSM, DIAMETER OF 6MM WIDTH X 4MM HEIGHT X 5MM DEPTH. AFTER DELIVERY OF A BALLOON CATHETER (TRANSFORM SUPER COMPLIANT 4MM X 10CM), PLACED IN THE VESSEL PAST THE ANEURYSM FOR SUPPORT DURING THE PROCEDURE, AN SL10 STRAIGHT TIP MICROCATHETER FOR COIL DELIVERY WAS PLACED INTO THE ANEURYSM. AN I-ED COIL COMPLEX SOFT (392-0620), LOT# KR033037 WAS DELIVERED THROUGH THE MICROCATHETER AND PLACED INTO THE ANEURYSM WITH ASSIST FROM THE BALLOON CATHETER TO DELIVER THE COIL INTO PLACE. THE COIL WAS DETACHED AND IMPLANTED WITHOUT PROBLEM. THE CONCERNED I-ED COIL 14 EXTRASOFT (373-040815) WAS SELECTED AS THE SECOND COIL AND DELIVERED THROUGH THE MICROCATHETER. THE FIRST HALF OF THE COIL WAS DELIVERED WITHOUT PROBLEM BUT FROM THERE THE PHYSICIAN EXPERIENCED CHALLENGES IN DELIVERING THE REMAINDER OF THE COIL AS SOME RESISTANCE WAS MET AND THE MICROCATHETER WAS KICKED OUT OF THE ANEURYSM AS THE COIL HERNIATED OUT. THE BALLOON CATHETER WAS INFLATED A NUMBER OF TIMES IN EFFORT TO KEEP THE COIL IN THE ANEURYSM BUT COULD NOT. AFTER SEVERAL ATTEMPT OF PULLING BACK AND REDELIVERY OF THE COIL, STRETCHING OF THE COIL WAS CONFIRM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18533695 ↗
• MalfunctionJan 17, 2024Fracture; Fracture

  BALLOON ASSISTED COIL EMBOLIZATION OF AN LEFT ICA (INTERNAL CAROTID ARTERY) ANEURYSM, DIAMETER OF 6MM WIDTH X 4MM HEIGHT X 5MM DEPTH. AFTER DELIVERY OF A BALLOON CATHETER (TRANSFORM SUPER COMPLIANT 4MM X 10CM), PLACED IN THE VESSEL PAST THE ANEURYSM FOR SUPPORT DURING THE PROCEDURE, AN SL10 STRAIGHT TIP MICROCATHETER FOR COIL DELIVERY WAS PLACED INTO THE ANEURYSM. AN I-ED COIL COMPLEX SOFT (392-0620), LOT# KR033037 WAS DELIVERED THROUGH THE MICROCATHETER AND PLACED INTO THE ANEURYSM WITH ASSIST FROM THE BALLOON CATHETER TO DELIVER THE COIL INTO PLACE. THE COIL WAS DETACHED AND IMPLANTED WITHOUT PROBLEM. THE CONCERNED I-ED COIL 14 EXTRASOFT (373-040815) WAS SELECTED AS THE SECOND COIL AND DELIVERED THROUGH THE MICROCATHETER. THE FIRST HALF OF THE COIL WAS DELIVERED WITHOUT PROBLEM BUT FROM THERE THE PHYSICIAN EXPERIENCED CHALLENGES IN DELIVERING THE REMAINDER OF THE COIL AS SOME RESISTANCE WAS MET AND THE MICROCATHETER WAS KICKED OUT OF THE ANEURYSM AS THE COIL HERNIATED OUT. THE BALLOON CATHETER WAS INFLATED A NUMBER OF TIMES IN EFFORT TO KEEP THE COIL IN THE ANEURYSM BUT COULD NOT. AFTER SEVERAL ATTEMPT OF PULLING BACK AND REDELIVERY OF THE COIL, STRETCHING OF THE COIL WAS CONFIRM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531822 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COIL EMBOLIZATION OF WAITING CASES OF INTERNAL CAROTID ARTERY C2 AND UNRUPTURED ANEURYSM. AFTER THE ASSIST STENT WAS PLACED, THE PRODUCT WAS USED AS THE FIRST FRAMING FROM THE MICROCATHETER THROUGH THE STENT STRUT. THE 3 CM TO 4 CM PART AT THE REAR END OF THE COIL DID NOT FOLD WELL AND THE LOOP CAME OUT OF THE STENT. WHILE MANIPULATING THE CATHETER TO CORRECT IT, THE COIL PIERCED THE AREA NEAR THE BLEB AT THE TIP OF THE ANEURYSM. THE PRODUCT WAS LEFT IN PLACE AS IT WAS, BUT THE COIL EXTENDED INTO THE SUBARACHNOID SPACE. WHILE EXPANDING THE BALLOON CATHETER NEAR THE ANEURYSM TO STOP BLEEDING, ANOTHER 6 COILS WERE PLACED FOR THE PURPOSE OF STOPPING BLEEDING, BUT THE BLEEDING DID NOT STOP EASILY. PROTAMINE WAS ADMINISTERED, AND FINALLY HEMOSTASIS WAS MAINTAINED FOR ABOUT 1 HOUR. ALTHOUGH THE PATIENT'S BLOOD PRESSURE WAS LOW, THE AMOUNT OF BLEEDING WAS LARGE, SO EXTERNAL VENTRICULAR DRAIN WAS PERFORMED AS IT WAS. AFTER DRAINAGE, A SLIGHT REDUCTION IN THE PUPIL WAS CONFIRMED, BUT SEVERE DISTURBANCE OF CONSCIOUSNESS REMAINED AND HE WAS HOSPITALIZED FOR FOLLOW-UP.

  Patient problems: Ruptured Aneurysm

  MAUDE report 10640576 ↗