TARGET M0035431030Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04546540698018), received between Nov 4, 2016 and Nov 27, 2024 — classified as 4 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (8 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Fracture; Fracture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT COIL DELIVERY WIRE WAS BROKEN/FRACTURED DURING USE. 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 20791884 ↗
• MalfunctionJan 29, 2024Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT COIL WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18597202 ↗
• MalfunctionDec 20, 2023Premature Separation; Premature Separation

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED IN THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369266 ↗
• MalfunctionApr 13, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL COULD NOT BE ADVANCED INTO PROXIMAL OF MICROCATHETER, DURING ADJUSTMENTS THE SUBJECT COIL DETACHED PREMATURELY INSIDE THE MICROCATHETER. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16737832 ↗
• MalfunctionDec 28, 2022Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE ANEURYSM EMBOLIZATION, THE SUBJECT COIL DETACHED UNEXPECTEDLY AND GOT STUCK IN MICROCATHETER. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16058114 ↗
• MalfunctionFeb 7, 2022Premature Separation; Premature Separation

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE COIL (SUBJECT DEVICE) WAS FOUND TO BE PREMATURELY DETACHED/SEPARATED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13477106 ↗
• InjuryJan 24, 2022Migration; Migration

  IT WAS REPORTED THAT PCOMA (POSTERIOR COMMUNICATING ARTERY) TINY ANEURYSM COIL EMBOLIZATION PROCEDURE WAS PERFORMED. THE SUBJECT COIL WAS IMPLANTED USING MICROCATHETER INTO THE ANEURYSM SUCCESSFULLY. TT WAS VERIFIED UNDER THE FLUOROSCOPY THAT THE SUBJECT COIL WAS DETACHED SUCCESSFULLY. WHEN THE PHYSICIAN TRIED TO RETRACT THE MICROCATHETER, THE IMPLANTED SUBJECT COIL MIGRATED WITH THE MICROCATHETER. SO HE USED A GUIDEWIRE AS A SNARE TO PUSH THE COIL OUT OF THE MICROCATHETER AND FOUND THAT THE GUIDEWIRE COULD NOT PASS THROUGH THE TIP OF THE MICROCATHETER EVEN AFTER SEVERAL TRIES. SO THE PHYSICIAN TRIED TO RETRACT THE MICROCATHETER AND FOUND THAT THE SUBJECT COIL WAS STUCK WITH TIP OF THE MICROCATHETER. SO THE PHYSICIAN WITHDREW THE COIL TOGETHER WITH THE MICROCATHETER FROM PATIENT VASCULATURE AND THE SUBJECT COIL WAS NOTED TO BE STRETCHED AND TAIL WAS STUCK WITH MICROCATHETER TIP. THE PHYSICIAN USED SOME FORCE TO SEPARATE THE COIL AND THE MICROCATHETER TIP. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE. 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 13339353 ↗
• MalfunctionNov 3, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE OF AN UNRUPTURED ANEURYSM, THE OPERATOR ATTEMPTED TO DELIVER THE SUBJECT COIL AS THE THIRD COIL TO THE TARGET LESION. THE SUBJECT COIL AND THE MICROCATHETER WERE ADJUSTED SEVERAL TIMES DUE TO TORTUOSITY AND STENOSIS OF THE PATIENTS VASCULAR ANATOMY. THE SUBJECT COIL GOT PREMATURELY DETACHED IN THE MICROCATHETER AND WAS DISCONTINUED TO USE. THE SUBJECT COIL 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 12747166 ↗
• MalfunctionSep 24, 2021Premature Separation; Premature Separation

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED DURING THE PROCEDURE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12528813 ↗
• MalfunctionJun 9, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING ACOMA ANEURYSM EMBOLIZATION PROCEDURE, WHEN THE PHYSICIAN FILLED THE COIL (SUBJECT DEVICE) INTO ANEURYSM FOR ABOUT 1/2, THE PHYSICIAN THOUGHT THE SHAPING WAS NOT GOOD SO RETRACTED IT TO ADJUST, BUT DURING PULLING THE COIL (SUBJECT DEVICE) BACK TO MICROCATHETER, THE PHYSICIAN FOUND UNDER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) THAT THE COIL (SUBJECT DEVICE) WAS DETACHED AND DROPPED IN MICROCATHETER. THE PHYSICIAN RE-POSITIONED THE MICROCATHETER AND REPLACED WITH A NEW COIL TO COMPLETE THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11970285 ↗
• MalfunctionNov 8, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) HAD DIFFICULTY ADVANCING INSIDE THE MICROCATHETER. WHEN THE SUBJECT COIL WAS REMOVED FROM THE PATIENT'S ANATOMY, IT WAS FOUND TO BE FRACTURED. THE PHYSICIAN USED A GUIDEWIRE TO REMOVE THE FRACTURED PART OF THE SUBJECT COIL FROM INSIDE THE MICROCATHETER. 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 10806439 ↗
• MalfunctionMay 1, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT FRICTION WAS EXPERIENCED WHILE ADVANCING THE SUBJECT COIL INSIDE THE MICRO CATHETER AND UPON REMOVAL, THE SUBJECT COIL WAS FOUND PREMATURELY DETACHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10019433 ↗
• InjuryAug 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, THE 3RD COIL (SUBJECT DEVICE) WAS DIFFICULT TO ADVANCE INTO THE MICROCATHETER AND STRETCH WAS CONFIRMED. THE SUBJECT COIL WAS RELIABLY RETRIEVED WITH A SNARE DEVICE AND THE PROCEDURE WAS FINISHED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8923564 ↗
• MalfunctionAug 2, 2019Break; Break

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) COULD NOT BE DELIVERED OUT OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED DIFFICULTY AND DURING WITHDRAWAL, THE COIL BROKE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8858052 ↗
• MalfunctionDec 17, 2018Break; Break

  IT WAS REPORTED THAT THE SUBJECT COIL WAS USED DURING COIL EMBOLIZATION FOR SUBARACHNOID HEMORRHAGE (SAH). RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SUBJECT COIL THROUGH THE MICROCATHETER AND THE COIL WAS REMOVED FROM THE PATIENT¿S BODY. THE PROXIMAL SECTION OF THE COIL WAS FOUND BROKEN. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8172200 ↗
• MalfunctionOct 10, 2018Break; Break

  BASED ON REVIEW OF THE INVESTIGATION OF THE RETURNED PRODUCT, IT WAS FOUND THAT THE MAIN COIL WAS BROKEN/FRACTURED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7954283 ↗
• InjuryAug 24, 2018Break; Unintended Movement; Migration; Break; Unintended Movement; Migration

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE COIL BROKE, PROTRUDED AND MIGRATED OUT OF THE ANEURYSM. THE PHYSICIAN USED A GUIDEWIRE TO PUSH THE COIL BACK INTO THE ANEURYSM AND PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7813931 ↗
• MalfunctionJul 26, 2018Break; Break

  DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REVEALED THAT THE MAIN COIL WAS BROKEN. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7724850 ↗
• InjuryDec 27, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE COIL DETACHED PREMATURELY INSIDE THE MICROCATHETER DURING MANIPULATION. THE COIL WAS RETRIEVED WITH A SNARE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7147190 ↗
• MalfunctionNov 4, 2016Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE COIL WOULD NOT TRACK AND BROKE. THE PHYSICIAN RETRACTED THE COIL AND USED ANOTHER COIL TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 6080345 ↗