TARGET XL M0036115150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327004571), received between Nov 21, 2016 and Jul 7, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE PHYSICIAN ADVANCED COIL (SUBJECT DEVICE) INSIDE THE PROXIMAL OF THE MICROCATHETER RESISTANCE WAS ENCOUNTERED. THEN THE SUBJECT COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE DETACHED SUBJECT COIL WAS REMOVED ALONG WITH THE 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 12131925 ↗
• MalfunctionDec 18, 2017Premature Activation; Premature Activation

  DURING THE COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE RESISTANCE WAS FELT WHEN ADVANCING THE SUBJECT COIL IN THE MICROCATHETER. SO THE PHYSICIAN REMOVED THE COIL AND THE COIL WAS PREMATURELY DETACHED IN THE MICROCATHETER. THEN THE DETACHED COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. THE SAME EVENT ALSO HAPPENED TO ANOTHER COIL USED IN THE PROCEDURE. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7127829 ↗
• MalfunctionDec 12, 2016Premature Activation; Premature Activation

  ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE MAIN COIL HAD DETACHED/SEPARATED FROM THE DELIVERY WIRE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6168675 ↗
• MalfunctionNov 21, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE REPOSITIONING OF THE COILS IN THE ANEURYSM, EACH DETACH MECHANICALLY AT THE DETACHMENT ZONE. EACH OF THE COILS WAS RESPECTIVELY REMOVED TOGETHER WITH THE MICROCATHETER EVERY TIME WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6117091 ↗