TARGET M0036182450Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327128376), received between Feb 7, 2017 and Dec 17, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Fracture; Premature Separation; Fracture; Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, RESISTANCE WAS ENCOUNTERED WHEN THE COIL WAS INSERTED IN THE MICROCATHETER AND DURING ITS ADVANCEMENT NEAR THE TIP OF MICROCATHETER. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE COIL LEADING TO DETACHMENT WITHIN THE MICROCATHETER. AN ATTEMPT WAS MADE TO PUSH AND PLACE THE DETACHED COIL HOWEVER IT COULD NOT BE PUSHED FORWARD. THE MAIN COIL WAS REPORTED TO BE STRETCHED, AND THE COIL DELIVERY WIRE WAS NOTED TO BE FRACTURED. THE SUBJECT DEVICE WAS REPLACED ALONG WITH THE MICROCATHETER, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23834563 ↗
• MalfunctionApr 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION OF A HEPATIC ARTERY ANEURYSM PROCEDURE, THE OPERATOR GUIDED A MICROCATHETER INTO THE ANEURYSM. WHEN THE OPERATOR WAS ADVANCING THE SUBJECT COIL AS THE SECOND COIL, RESISTANCE WAS ENCOUNTERED IN THE SHAFT AS WELL AS DURING COIL WITHDRAWAL. WHEN THE SUBJECT COIL WAS RETRIEVED, IT WAS CONFIRMED THAT IT HAD BEEN FRACTURED FROM THE DELIVERY WIRE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938170 ↗
• MalfunctionAug 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SPLENIC ARTERY ANEURYSM PROCEDURE, THE SUBJECT COIL DETACHED WITHIN THE MICROCATHETER WHEN THE DELIVERY WIRE WAS RETRACTED DUE TO RESISTANCE AT THE DISTAL OF THE MICROCATHETER. THE PHYSICIAN REPLACED THE CATHETER AND SUBJECT COIL WITH NEW DEVICES AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15176310 ↗
• MalfunctionJun 17, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT A PERIPHERAL VASCULAR SURGERY WAS PERFORMED IN A PATIENT WITH SPLENIC VARICOSE VEIN IN A BRTO CASE. DURING THE PROCEDURE WHEN THE SUBJECT COIL WAS ADVANCED THROUGH THE MICROCATHETER, CONSIDERABLE RESISTANCE WAS FELT AND COULD NOT BE ADVANCED. AN ATTEMPT WAS MADE TO DELIVER SUBJECT COIL BY CHANGING THE POSITION OF THE MICROCATHETER, STILL THE SUBJECT COIL COULD NOT BE DELIVERED TO THE TARGET LESION. THE OPERATOR DECIDED TO RETRIEVE THE SUBJECT COIL. WHEN THE SUBJECT COIL DELIVERY WIRE WAS RETRACTED FROM THE MICROCATHETER, THE SUBJECT COIL PREMATURELY DETACHED INTO THE LUMEN OF THE MICROCATHETER. UNSUCCESSFUL ATTEMPT WAS MADE TO PUSH THE PREMATURELY DETACHED SUBJECT COIL OUT OF THE MICROCATHETER USING A GUIDE WIRE. THE SUBJECT ALONG WITH THE MICROCATHETER WERE RETRIEVED OUT OF THE PATIENTS ANATOMY. IN THE PHYSICIANS OPINION THE PATIENT HAD A VERY TORTUOUS VASCULAR ANATOMY AND THE SUBJECT COIL WAS INSERTED WITH CONSIDERABLE RESISTANCE AND WAS PULLED IN AND OUT, THIS CAUSED THE PREMATURELY DETACHMENT OF THE SUBJECT COIL. THE SUBJECT COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14726713 ↗
• MalfunctionSep 8, 2021Premature Separation; Premature Separation

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE MAIN COIL PREMATURELY DETACHED/SEPARATED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12441900 ↗
• MalfunctionNov 18, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE COIL(SUBJECT DEVICE) INTO THE OTHER COMPANY MICRO CATHETER, AND THE SUBJECT COIL WAS DIFFICULT TO BE PLACED INTO THE ANEURYSM AT THE INTERNAL ILIAC ARTERY, AND WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE SUBJECT COIL, IT GOT STRETCHED AND THEN IT PREMATURELY DETACHED INSIDE THE MICRO CATHETER INSIDE THE PATIENT'S ANATOMY DURING THE PROCEDURE. THE PHYSICIAN RETRACTED THE DETACHED COIL AND MICROCATHETER FROM THE VESSEL AND THE SAME MICRO CATHETER WAS USED AGAIN TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9335721 ↗
• MalfunctionJun 4, 2019Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL WAS PREMATURELY DETACHED INSIDE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8667408 ↗
• MalfunctionOct 17, 2018Break; Break

  IT WAS REPORTED THAT THE SUBJECT DEVICE COIL WAS BROKEN DURING INSERTION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7975993 ↗
• MalfunctionFeb 7, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION, THERE WAS DIFFICULTY POSITIONING THE SUBJECT COIL IN THE ANEURYSM. THEREFORE THE PHYSICIAN ATTEMPTED TO PULL THE SUBJECT COIL OUT OF THE PATIENT. WHILE RETRACING, THE SUBJECT COIL WAS PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER AND THE COIL AS ONE UNIT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6309488 ↗