TARGET XL M0036102050Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327004731), received between Mar 14, 2017 and Aug 30, 2024 — classified as 3 injuries, 4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE SUBJECT COIL WITHIN THE MICROCATHETER AND REQUIRED FORCE TO PUSH. ONCE THE SUBJECT COIL WAS VISIBLE THE DELIVERY WIRE OF THE SUBJECT COIL WAS PULLED BACK BUT THE SUBJECT COIL HAD DETACHED PREMATURELY IN THE MICROCATHETER. 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

  MAUDE report 20110379 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE IN A PATIENT WITH INTERNAL CAROTID ARTERY ANEURYSM, THE SUBJECT COIL GOT STUCK IN THE MICROCATHETER, THE PHYSICIAN REMOVED THE SUBJECT COIL TOGETHER WITH THE MICROCATHETER OUT OF THE PATIENT VASCULATURE. THE PHYSICIAN DEPLOYED A FLOW DIVERTER STENT AND THEN ATTEMPTED TO DEPLOY COIL FROM POSTERIOR CIRCULATION. THERE WAS A SURGICAL DELAY OF 1 HOUR AND IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNKNOWN ADVERSE CONSEQUENCES DUE TO THE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15332156 ↗
• MalfunctionJul 24, 2020Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL WAS PREMATURELY DETACHED/SEPARATED INSIDE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10323796 ↗
• MalfunctionFeb 5, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE COIL (SUBJECT DEVICE) USED WAS RELEASED WITHIN THE MICROCATHETER PRIOR TO BEING IMPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9674708 ↗
• MalfunctionSep 6, 2018Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED AT THE JUNCTION WITHOUT ANY DETACHMENT ATTEMPT. HOWEVER, THE COIL WAS ENTIRELY PLACED INSIDE THE ANEURYSM. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7852605 ↗
• InjuryAug 9, 2018Fracture; Premature Separation; Fracture; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF A BIG ANEURYSM, THE SUBJECT COIL DETACHED PREMATURELY AND A VERY TINY FILAMENT WAS OBSERVED. THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE MICROCATHETER; THEREFORE, THE COIL WAS RETRIEVED WITH THE MICROCATHETER. THE FILAMENT WAS LEFT INSIDE THE PATIENT¿S ARTERY. NO OTHER PATIENT CONSEQUENCES REPORTED. NO OTHER ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7768929 ↗
• InjuryMar 14, 2017Migration or Expulsion of Device; Premature Activation; Migration or Expulsion of Device; Premature Activation

  DURING PLACEMENT OF THE FIRST COIL 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 (SUBJECT DEVICE) 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: Device Embedded In Tissue or Plaque

  MAUDE report 6405002 ↗