TARGET M0035476150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540676535), received between Aug 14, 2018 and Mar 4, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2024Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE COIL (SUBJECT DEVICE) WAS SEEN TO BE 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 18833987 ↗
• InjuryMar 4, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL WAS STRETCHED WHILE THE PHYSICIAN WAS RETRACTING IT BACK INTO THE MICRO CATHETER. THE STRETCHED PART OF THE SUBJECT COIL BROKE OUTSIDE THE ANEURYSM AND WAS LEFT INSIDE THE PATIENT. SURGICAL DELAY OF UNKNOWN TIME WAS REPORTED DURING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT WILL HAVE TO FOLLOW UP FOR FURTHER TREATMENT BUT NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11416423 ↗
• MalfunctionAug 14, 2018Break; Break

  ANALYSIS OF THE DEVICE REVEALED THAT THE COIL DELIVERY WIRE WAS BROKEN. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7783613 ↗