TARGET M0035474060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540676450), received between Apr 30, 2018 and Nov 8, 2023 — classified as 1 injury, 1 malfunction.

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

• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING THE COIL EMBOLIZATION FOR AN UNRUPTURED CEREBRAL ANEURYSM IN A-COM (THE ANTERIOR COMMUNICATING ARTERY), THE SUBJECT COIL WAS GUIDED USING WITH A STRYKER CATHETER, AND WHILE REPOSITIONING SEVERAL TIMES TO ENGAGE WITH THE VESSEL, A RESISTANCE WAS ENCOUNTERED. FLUOROSCOPIC IMAGES SHOWED THAT PROXIMAL OF THE SUBJECT COIL SEEMED TO BE STRETCHED, SO IT WAS OPERATED MORE CAREFULLY AND PERFORMED THE DETACHMENT WITH THE MARKER IN THE APPROPRIATE POSITION, BUT THE SUBJECT COIL COULD NOT BE DETACHED. IT WAS REMOVED BY THE PHYSICIAN WITH A SNARE DEVICE. THE SUBJECT COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097634 ↗
• MalfunctionApr 30, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING THE COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN THOUGHT THE FIRST COIL (SUBJECT DEVICE) WAS SMALLER THAN THE SIZE ON THE LABEL. HOWEVER, HE STILL DETACHED THE COIL. THEN THE PHYSICIAN ADVANCED THE SECOND COIL AND BIG RESISTANCE WAS FELT IN THE MICROCATHETER. SO HE WITHDREW THE SECOND COIL, BUT THE FIRST COIL CAME OUT WITH THE SECOND COIL TOGETHER AND THE FIRST COIL WAS FOUND STRETCHED. THE PROCEDURE WAS COMPLETED WITH OTHER COILS. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7473166 ↗