TARGET M0035424510Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540714763), received between Jun 25, 2019 and Aug 15, 2025 — classified as 3 malfunctions.

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

• MalfunctionAug 15, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF ANTERIOR COMMUNICATING (A-COM) ARTERY RUPTURED ANEURYSM PROCEDURE; THE SUBJECT COIL WAS USED AS THE FIRST COIL. ALTHOUGH THE COIL WAS REPOSITIONED, IT DID NOT ENGAGE WITH THE VESSEL. THUS, THE OPERATOR ATTEMPTED TO RETRACT THE SUBJECT COIL, HOWEVER, THE SUBJECT COIL WAS RETRACTED IN THE OPPOSITE SIDE OF THE INTRODUCER SHEATH. THE MICROCATHETER WAS ADVANCED TO THE ANEURYSM, AND THE SUBJECT COIL WAS INSERTED WITH STRONG RESISTANCE. THE OPERATOR PUSHED THE COIL HARD, WHICH RESULTED IN PREMATURE DETACHMENT OF THE SUBJECT COIL WITHIN THE MICROCATHETER'S SHAFT. THE SUBJECT COIL WAS REMOVED WITH THE ENTIRE MICROCATHETER. 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 22820138 ↗
• MalfunctionJan 8, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN FACED RESISTANCE WHILE INSERTING THE SUBJECT COIL INSIDE THE MICRO CATHETER. WHEN THE SUBJECT COIL WAS WITHDRAWN IT GOT STRETCHED. THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCE TO THE PATIENT. THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT COIL WAS BROKEN DURING USE; THEREFORE, THIS EVENT MEETS REPORTING CRITERIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11141070 ↗
• MalfunctionJun 25, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL HAD PREMATURELY DETACHED INSIDE THE MICROCATHETER AND HAD REMAINED STUCK, DURING PREPARATION OF THE DEVICE. THE COIL WAS RETRIEVED ALONG WITH THE MICROCATHETER. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8732830 ↗