TARGET M0035471230Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252192671), received between Mar 29, 2019 and Jan 8, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJan 8, 2026Fracture

  IT WAS REPORTED THAT DURING MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM PROCEDURE, THE OPERATOR POSITIONED THE LONG SHEATH AND INTERMEDIATE CATHETER AND SUPER-SELECTIVELY ADVANCED ONE MICROCATHETER TO THE DISTAL M2 SEGMENT TO SERVE AS THE STENT MICROCATHETER, WHILE ANOTHER MICROCATHETER WAS DELIVERED TO THE ANEURYSM SITE. A SUBJECT COIL WAS THEN INTRODUCED. DURING THE DELIVERY PROCESS, THE OPERATOR FELT RESISTANCE AND WITHDREW THE SUBJECT COIL, DISCOVERING THAT ITS TIP HAD FRACTURED. THE OPERATOR THEN WITHDREW THE ENTIRE COIL MICROCATHETER, WITH THE FRACTURED PORTION OF THE SUBJECT COIL REMAINING INSIDE. 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 24015940 ↗
• MalfunctionFeb 22, 2022Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT COIL DEPLOYED PREMATURELY 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 13579166 ↗
• MalfunctionMar 29, 2019Break; Break

  IT WAS REPORTED THAT DURING AN ANEURYSM CASE, WHEN ADVANCING THE SUBJECT COIL INSIDE THE MICROCATHETER, THE RESISTANCE WAS ENCOUNTERED, THEREFORE; THE SUBJECT COIL WAS WITHDRAWN, AND IT WAS FOUND TO BE BROKEN IN THE MICROCATHETER. THE SUBJECT COIL AND MICROCATHETER WERE REMOVED TOGETHER AS A UNIT. THE OPERATOR REPLACED THEM WITH A NEW MICROCATHETER AND NEW COIL TO FINISH THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8467126 ↗