Target M0035433080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540676085), received between Oct 9, 2020 and Jun 21, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (1 report).

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.

• MalfunctionJun 21, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN ADVANCING THE SUBJECT COIL DURING THE PROCEDURE, AND UPON REMOVAL, STRETCHED AND PREMATURELY DETACHED OF THE COIL WERE NOTED. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033635 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN THE SUBJECT COIL WAS ATTEMPTED TO INSERT, A BLOOD CLOT WAS INDUCED, AND THE LEFT ACA (ANTERIOR CEREBRAL ARTERY) IS BLOCKED. THERE IS A GREAT POSSIBILITY THAT BLOOD FLOW WILL BE BLOCKED, AND THE DISORDER WILL REMAIN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Thromboembolism

  MAUDE report 10771036 ↗
• MalfunctionOct 9, 2020Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE MAIN COIL WAS BROKEN/FRACTURED DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10659847 ↗