TARGET XL M0036101040Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540711274), received between Mar 29, 2017 and Jun 4, 2024 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COILING OF THE ICA (INTERNAL CAROTID ARTERY) PROCEDURE, THE COIL (SUBJECT DEVICE) DETACHED PREMATURELY WITHIN THE MICROCATHETER. THE COIL (SUBJECT DEVICE) AND THE MICROCATHETER WERE SUCCESSFULLY REMOVED AND REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462522 ↗
• MalfunctionJan 22, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL DETACHED PREMATURELY INSIDE THE CATHETER. NO FURTHER INFORMATION AVAILABLE. UPDATE: IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL WAS IMPOSSIBLE TO FIT IT INTO THE MICROCATHETER. WHEN THE MICROCATHETER WAS WITHDRAWN, THE SUBJECT COIL WAS FOUND TO BE BLOCKED INSIDE. THERE WAS 20 MINUTES SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18559979 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT COIL STRETCHED INSIDE THE PATIENT AND A SNARE WAS USED TO RETRIEVE IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218782 ↗
• MalfunctionApr 11, 2022Migration; Migration

  IT WAS REPORTED THAT WHEN RETRIEVING THE COIL (SUBJECT DEVICE), IT WAS PULLED SLOWLY AND MOVED. THE COIL (SUBJECT DEVICE) WAS STRETCHED. IT IS UNKNOWN IF THE COIL (SUBJECT DEVICE) MIGRATED AFTER BEING DETACHED. 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 14069765 ↗
• MalfunctionApr 5, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS PREMATURELY DETACHED WHILE THE PHYSICIAN ADVANCING THE SUBJECT COIL 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 14018057 ↗
• MalfunctionApr 6, 2020Separation Failure; Separation Failure

  ANALYSIS OF THE RETURNED DEVICE FOUND THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED INSIDE THE PATIENT DURING THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9929557 ↗
• MalfunctionApr 18, 2019Premature Separation; Premature Separation

  WHILE WITHDRAWING THE COIL (SUBJECT DEVICE), THE PHYSICIAN EXPERIENCED FRICTION AND THE COIL DEPLOYED WITHIN THE MICROCATHETER. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8529975 ↗
• MalfunctionSep 25, 2017Break; Break

  DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REVEALED THAT THE MAIN COIL WAS BROKEN AT THE DETACHMENT ZONE. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6891132 ↗
• MalfunctionApr 10, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION, RESISTANCE WAS EXPERIENCED AS THE COIL WAS BEING ADVANCED THROUGH THE MICROCATHETER. THE PHYSICIAN PULL BACK THE COIL AND ONLY THE DELIVERY WIRE CAME OUT. THE COIL WAS STUCK INSIDE THE MICROCATHETER. THE COIL AND MICROCATHETER WERE REMOVED FROM PATIENT¿S BODY WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6478563 ↗
• MalfunctionMar 29, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT WHEN THE COIL WAS ADVANCED IN THE MICROCATHETER, THE COIL EXPERIENCED RESISTANCE AND DETACHED PREMATURELY. THE COIL WAS RETRIEVED ALONG WITH THE MICROCATHETER FROM THE PATIENT'S ANATOMY WITHOUT CLINICAL CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6444281 ↗