TARGET XL M0036102450Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327004755), received between Aug 28, 2020 and Mar 19, 2024 — classified as 2 injuries, 2 malfunctions.

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

• MalfunctionMar 19, 2024Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE COIL (SUBJECT DEVICE) DELIVERY WIRE WAS BROKEN/FRACTURED DURING USE. 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 18933921 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE 4 COILS (SUBJECT DEVICE) WERE IMPLANTED. POST PROCEDURE, THE PATIENT SUFFERED SEVERE HEADACHE & INCREASING COMPRESSION SYMPTOMS (ABDUCENS NERVE). THREE WEEK CORTISONE THERAPY WAS PRESCRIBED TO CURE THE ADVERSE EVENT AND THE ADVERSE EVENT OF HEADACHE WAS RESOLVED IN 5 DAYS.

  Patient problems: Headache; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14109900 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE 4 COILS (SUBJECT DEVICE) WERE IMPLANTED. POST PROCEDURE, THE PATIENT SUFFERED SEVERE HEADACHE & INCREASING COMPRESSION SYMPTOMS (ABDUCENS NERVE). THREE WEEK CORTISONE THERAPY WAS PRESCRIBED TO CURE THE ADVERSE EVENT AND THE ADVERSE EVENT OF HEADACHE WAS RESOLVED IN 5 DAYS.

  Patient problems: Headache; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14109812 ↗
• MalfunctionAug 28, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE WHILE ADVANCING THE SUBJECT COIL IT DETACHED PREMATURELY IN THE MICRO CATHETER. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10466148 ↗