TARGET XL M0036121850Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540711564), received between Jan 22, 2020 and Feb 26, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT COIL GOT DETACHED IN THE MICROCATHETER WITHOUT THE POWER SUPPLY AND THE SUBJECT COIL WAS PUSHED SUCCESSFULLY IN THE ANEURYSM USING PHYSIOLOGICAL SOLUTION AND A SYRINGE. 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 24451223 ↗
• MalfunctionDec 16, 2025Premature Separation; Premature Separation

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT COIL WAS PREMATURELY DETACHED/SEPARATED 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 23824424 ↗
• MalfunctionOct 10, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM, THE SUBJECT COIL PREMATURELY DETACHED INSIDE 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 17906484 ↗
• MalfunctionSep 9, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE THE SUBJECT COIL ENCOUNTERED RESISTANCE WHILE ADVANCING THE SUBJECT COIL WITHIN THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. ANALYSIS OF THE RETURNED DEVICE FOUND THE MAIN COIL PREMATURELY DETACHED/SEPARATED 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 12444401 ↗
• MalfunctionJan 22, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL PREMATURELY DETACHED WHILE BEING ADVANCED INSIDE THE MICRO CATHETER. THE PHYSICIAN REPLACED THE COIL AND COMPLETED THE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9617960 ↗