TARGET M0035474150Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04546540676481), received between Dec 15, 2016 and Mar 25, 2026 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF THE SUBARACHNOID HEMORRHAGE (SAH), THE SUBJECT COIL PREMATURELY DETACHED DURING USE AND WAS PUSHED INTO THE COIL MASS BY THE COIL DELIVERY WIRE. 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 24684410 ↗
• MalfunctionDec 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT COIL WAS USED DURING THE PROCEDURE. THE PHYSICIAN ENCOUNTERED LOT OF RESISTANCE WHILE PUSHING THROUGH THE MICROCATHETER. THE SUBJECT COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT SUBJECT COIL DELIVERY WIRE WAS FOUND TO BE FRACTURED NEAR THE PROXIMAL END AND THE SUBJECT MAIN COIL WAS NOTED TO BE FRACTURED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874119 ↗
• InjuryJun 4, 2025Expulsion; Expulsion

  IT WAS REPORTED THAT DURING PROCEDURE, AFTER DEPLOYMENT OF THE SUBJECT DEVICE, IT WAS HERNIATED FROM THE ANEURYSM AND THE SUBJECT DEVICE WAS RETRIEVED FROM THE PATIENT. THEREFORE, THE ADDITIONAL STENT AND TWO COILS WERE IMPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146775 ↗
• InjuryDec 13, 2024Fracture; Expulsion; Fracture; Expulsion

  IT WAS REPORTED DURING A RUPTURED ANEURYSM COILING CASE, DURING DEPLOYMENT OF THE SECOND COIL (SUBJECT DEVICE), A LOOP OF COIL HERNIATED OUT OF THE ANEURYSM AND INTO THE RIGHT INTERNAL CAROTID ARTERY (ICA). WHILE PULLING THIS LOOP OF COIL BACK INTO THE MICROCATHETER, THE LOOP OF COIL BROKE OFF AND PARTIALLY DEPLOYED IN THE RIGHT ICA. MULTIPLE SNARES WERE USED TO TRY TO REMOVE THE COIL FROM THE RIGHT ICA, BUT THIS WAS UNSUCCESSFUL. RIGHT INTERNAL CAROTID ARTERY CEREBRAL ANGIOGRAM SHOWED NO THROMBUS FORMATION ON THE LOOP OF COIL AND NO STENOSIS OR FLOW LIMITATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 20923073 ↗
• MalfunctionFeb 26, 2021Premature Separation; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS ON (B)(6) 2020 AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT COIL HAD PREMATURELY DEPLOYED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11387932 ↗
• MalfunctionJan 20, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL WAS NOTED TO BE BROKEN AT THE HAND PART DURING COIL DELIVERY. THE PHYSICIAN WAS ABLE TO COLLECT THE SUBJECT DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11205756 ↗
• MalfunctionSep 1, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS DETACHED VOLUNTARILY AND AS INTENDED. WHEN THE PHYSICIAN TRIED TO REMOVE THE DELIVERY WIRE, STRONG RESISTANCE WAS FELT. ON VISUAL CONFIRMATION, DAMAGE TO THE DELIVERY WIRE WAS CONFIRMED. THE PROCEDURE WAS COMPETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT. THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE COIL DELIVERY WIRE WAS BROKEN/FRACTURED DURING USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10480760 ↗
• MalfunctionMay 14, 2019Break; Break

  ANALYSIS OF THE RETURNED DEVICE FOUND THE MAIN COIL BROKEN/FRACTURED. THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8609241 ↗
• InjuryJan 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN THE SUBJECT COIL WAS REPOSITIONED BEFORE IT DEPLOYED IN THE ANEURYSM, AND THE PROXIMAL PART OF THE COIL WAS STRETCHED. THE PHYSICIAN THEN USED A MICROCATHETER AND A SNARE DEVICE TO REMOVE THE STRETCHED COIL FROM THE PATIENT¿S ANATOMY. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8295186 ↗
• MalfunctionSep 17, 2018Break; Break

  IT WAS REPORTED THAT THE SUBJECT DEVICE (COIL) WAS BROKEN DURING WITHDRAWAL. ANOTHER PRODUCT WAS INSERTED AND THEN THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7883139 ↗
• InjuryAug 17, 2018Break; Break

  IT WAS REPORTED THAT DURING A CEREBRAL ANEURYSM COIL EMBOLIZATION, THE COIL (SUBJECT DEVICE) DID NOT DETACH. DURING THE RECOVERY ATTEMPTS, THE COIL BROKE. THE COIL WAS RECOVERED BY MEANS OF A LASSO. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7793242 ↗
• MalfunctionNov 29, 2017Break; Break

  ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE MAIN COIL WAS BROKEN. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7069610 ↗
• MalfunctionOct 27, 2017Break; Break

  ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE COIL DELIVERY WIRE WAS BROKEN. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6983720 ↗
• MalfunctionMay 4, 2017Break; Break

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGING AND FLUSHING THE PRODUCT, THE COIL (SUBJECT DEVICE) WAS SUSPECTED TO BE BROKEN. THE COIL WAS NOT USED AND REPLACED WITH A SPARE ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 6546456 ↗
• MalfunctionDec 15, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT WHEN ABOUT 3 CM OF THE MAIN COIL WAS REMAINING TO BE ADVANCED INSIDE THE ANEURYSM, THE COIL WAS REPOSITIONED; HOWEVER, RESISTANCE WAS FELT AND THE COIL WAS STUCK INSIDE THE ANEURYSM. WHILE THE PHYSICIAN WAS ATTEMPTING TO RETRIEVE THE COIL, THE PROXIMAL PART OF THE COIL STRETCHED AND IT WAS MECHANICALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN REMOVED THE DETACHED COIL ALONG WITH THE MICROCATHETER FROM THE PATIENT'S BODY WITHOUT CLINICAL CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6176134 ↗