TARGET XL M0036101850Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327004724), received between Dec 20, 2016 and Mar 28, 2024 — classified as 2 injuries, 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 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.

• MalfunctionMar 28, 2024Premature Separation; Premature Separation

  IT WAS REPORTED DURING A CEREBRAL ANEURYSM EMBOLIZATION PROCEDURE, THE SUBJECT COIL WAS UNABLE TO POSITION FIRMLY AT THE TREATMENT SITE. AS THE SUBJECT COIL WAS BEING RETRACTED FROM THE CATHETER, IT PREMATURELY DETACHED. THE ENTIRE CATHETER WAS WITHDRAWN FROM THE PATIENT WITH THE SUBJECT COIL. THE SUBJECT COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18997245 ↗
• MalfunctionJul 5, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS FOUND PREMATURELY DEPLOYED INSIDE THE MICROCATHETER. NO FURTHER INFORMATION AVAILABLE AND THERE WAS NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 14916048 ↗
• InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) WAS STRETCHED WHILE BEING INSERTED INTO THE MICRO CATHETER AND THE SNARE SYSTEM WAS USED TO COLLECT THE STRETCHED COIL. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9042020 ↗
• InjuryMar 14, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING PLACEMENT OF THE FIRST COIL (SUBJECT DEVICE) INTO A PULMONARY ARTERIOVENOUS FISTULA, AS THE FIRST COIL WAS PLACED, IT JAMMED AND STRETCHED. UNSUCCESSFULLY ATTEMPTS TO SNARE THE COIL WERE PERFORMED. THE STRETCHED PORTION OF THE FIRST COIL REMAINED IN THE PATIENT VESSEL. THE PHYSICIAN CONTINUED THE PROCEDURE BY PLACING A SECOND COIL FOLLOWED BY UNSUCCESSFUL DETACHMENT ATTEMPTS. IT WAS REPORTED THAT WHEN SECOND COIL WAS BEING REMOVED, IT DETACHED PREMATURELY REMAINING UN-RETRIEVED INSIDE THE PULMONARY ARTERY. THE EVENT INDICATED THAT TO PREVENT THE COIL FROM MIGRATION IT WAS SECURED BY DEPLOYING 20 COILS TO OCCLUDE THE FISTULA WITHOUT ANY PROBLEM. PATIENT CURRENT CONDITION WAS REPORTED AS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6404419 ↗
• MalfunctionDec 20, 2016Break; Break

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION, WHILE ATTEMPTING TO RETRIEVE THE SUBJECT COIL, THE COIL BROKE IN THE MICROCATHETER. BOTH THE COIL AND THE MICROCATHETER WAS REMOVED AS A SINGLE PIECE. NO CONSEQUENCES TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6190201 ↗