Target M0035433060Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540676078), received between Aug 29, 2018 and Nov 22, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE OPERATOR ENCOUNTERED RESISTANCE WHEN PUSHING THE SUBJECT COIL INTO THE MICROCATHETER. WHEN THE OPERATOR WAS PULLING THE SUBJECT COIL BACK, IT DETACHED FROM THE WIRE AND BECAME STUCK IN THE STROKE OF THE CATHETER. A 10-MINUTE SURGICAL DELAY WAS REPORTED DUE TO THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23625022 ↗
• MalfunctionMay 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN DELIVERING THE SUBJECT COIL SIGNIFICANT RESISTANCE WAS ENCOUNTERED WITHIN THE MICROCATHETER. THE OPERATOR MANAGED TO PUSH THE SUBJECT COIL OUT OF THE MICROCATHETER TO FILL THE ANEURYSM. WHEN ATTEMPTING TO DETACH IT, THE SUBJECT COIL WOULD NOT ADVANCE. THE OPERATOR THEN WITHDREW THE SUBJECT COIL AND FOUND THAT ITS DETACHMENT POINT HAD FRACTURED. 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 19262442 ↗
• MalfunctionFeb 20, 2023Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT MAIN COIL 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 16404353 ↗
• MalfunctionSep 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) COULD NOT BE DETACHED AFTER IT WAS ADVANCED INTO LUMEN OF ANEURYSM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE COIL (SUBJECT DEVICE) DELIVERY WIRE WAS BROKEN/FRACTURED DURING USE. 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 15376284 ↗
• MalfunctionNov 18, 2019Premature Separation; Premature Separation

  DURING THE COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN THOUGHT THE COIL (SUBJECT DEVICE) WAS DETACHED AFTER HEARING THREE BEEP SOUND FROM THE POWER SUPPLY. HOWEVER, WHEN THE PHYSICIAN WAS RETRACTING THE DELIVERY WIRE, HE OBSERVED THAT THE COIL CAME ALONG WITH THE DELIVERY WIRE AND WAS DETACHED IN THE MICROCATHETER. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9335712 ↗
• MalfunctionAug 29, 2018Break; Break

  IT WAS REPORTED THAT THE PHYSICIAN BROKE THE COIL DURING PREPARATION WHILE REMOVING THE COIL FROM THE HOOP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7830984 ↗