TARGET XL M0036124080Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327128390), received between Sep 13, 2017 and Dec 18, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Positioning Failure; Expulsion; Positioning Failure; Expulsion

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT DEVICE WAS HERNIATED, HOWEVER, ACCORDING TO PROCEDURE NOTES AND THE SUBJECT DEVICE WAS NEVER DEPLOYED DUE TO DIFFICULTIES IN ACCESSING THE TARGET LOCATION. NO OTHER INFORMATION WAS PROVIDED. UPDATE: RECEIVED ADDITIONAL INFORMATION ON (B)(6) 2026 CONFIRMED THAT THE SUBJECT COIL WAS NEVER DEPLOYED DUE TO DIFFICULTIES IN ACCESSING THE TARGET LOCATION AND IT WAS WITHDRAWN FROM THE PATIENT. BASED ON THE INFORMATION, THIS EVENT DOES NOT MEET REPORTING CRITERIA ANYMORE . THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENT OF THE REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838583 ↗
• MalfunctionNov 18, 2025Fracture; Premature Separation; Fracture; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS REPORTED FOR ENCOUNTERING RESISTANCE WHILE ADVANCING FROM THE INTRODUCER SHEATH INTO THE MICROCATHETER AND THROUGH THE MICROCATHETER. HOWEVER, WHEN THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS, IT WAS FOUND THAT THE COIL DELIVERY WIRE WAS KINKED, THE MAIN COIL WAS STRETCHED AND HAD SUTURE DAMAGE. ALSO, THE MAIN COIL WAS FOUND TO BE PREMATURELY DETACHED DURING USE AND WAS BROKEN/FRACTURED DURING USE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585682 ↗
• MalfunctionNov 6, 2025Fracture; Fracture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE MAIN COIL 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 23493371 ↗
• MalfunctionApr 19, 2023Premature Separation; Premature Separation

  DURING THE COIL EMBOLIZATION PROCEDURE FOR TREATING CAROTID-CAVERNOUS FISTULA, RESISTANCE WAS ENCOUNTERED WITHIN THE MICROCATHETER. WHEN THE SUBJECT COIL WAS RETRIEVED, IT PREMATURELY DETACHED WITHIN THE MICROCATHETER. THE SUBJECT COIL ALONG WITH THE MICROCATHETER WAS REMOVED OUT OF THE PATIENT¿S BODY AND SUBJECT DEVICE WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME MICROCATHETER WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16768268 ↗
• MalfunctionJan 18, 2022Premature Separation; Premature Separation

  IT WAS REPORTED DURING A CORONARY EMBOLIZATION TREATMENT PROCEDURE THE SUBJECT COIL PREMATURELY DETACHED IN THE CATHETER. THE COIL WAS RETRIEVED WITH THE CATHETER AND WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13285837 ↗
• MalfunctionDec 20, 2019Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS RESISTANCE WHEN THE COIL (SUBJECT DEVICE) WAS ADVANCED INTO THE CATHETER. THE PHYSICIAN WAS ABLE TO REMOVE THE COIL AND IT WAS FOUND BROKEN IN CATHETER. THE COIL WAS REPLACED WITH ANOTHER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9507503 ↗
• MalfunctionDec 5, 2019Premature Separation; Premature Separation

  DURING THE COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) COULD NOT BE PLACED WELL. SO THE PHYSICIAN DECIDED TO REMOVE IT, HOWEVER, THE MAIN COIL WAS PREMATURELY DETACHED IN THE MICROCATHETER DURING REMOVAL. THEN THE COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER REPLACING THE COIL. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9416143 ↗
• MalfunctionNov 1, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE DELIVERY WIRE OF THE SUBJECT COIL WAS BROKEN AND REMAINED INSIDE THE DETACHMENT SYSTEM DURING THE PROCEDURE. THE COIL WHICH WAS PLACED IN THE ANEURYSM WAS RETRACTED. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9269231 ↗
• MalfunctionNov 14, 2018Material Protrusion/Extrusion; Material Protrusion/Extrusion

  DURING THE FOLLOW UP, IMAGING CONFIRMED PART OF THE COIL WAS PROTRUDING OUT OF THE SECOND DIVISION OF THE ANTERIOR CEREBRAL ARTERY-A2 SEGMENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8070515 ↗
• InjurySep 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM LOCATED IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION. POST-PROCEDURE THE PATIENT WAS ASSESSED HAVING A MRS OF 0. IT WAS REPORTED THAT 9 MONTHS POST PROCEDURE, THE PATIENT EXPERIENCED BILATERAL WEAKNESS. THE BILATERAL WEAKNESS WAS ONGOING AND A MRI PROCEDURE WAS PERFORMED SHOWING STABLE FINDINGS CONSISTENT WITH CHRONIC SMALL VESSEL ISCHEMIC WHITE MATTER CHANGE. NO INFARCTION WAS IDENTIFIED. ACCORDING TO THE PHYSICIAN, THE BILATERAL WEAKNESS WAS UNRELATED TO THE PROCEDURE AND STENTS. HOWEVER IT IS UNKNOWN IF THE BILATERAL WEAKNESS WAS RELATED TO THE IMPLANTED COILS (SUBJECT DEVICES). THE PATIENT WAS ASSESSED HAVING A MRS OF 0 AT 2, 6 AND 12 MONTHS AND A NIHHS OF 0 AT 12 MONTHS POST THE INDEX PROCEDURE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 6870484 ↗
• InjurySep 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION OF AN UN-RUPTURED ANEURYSM LOCATED IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION. POST-PROCEDURE THE PATIENT WAS ASSESSED HAVING A MODIFIED RANKING SCALE (MRS) OF 0. AT TWO MONTHS FOLLOW-UP VISIT, THE PATIENT WAS ASSESSED HAVING A MRS OF 0. IT WAS REPORTED THAT 6 MONTHS FOLLOW-UP POST THE INDEX PROCEDURE, THE PATIENT EXPERIENCED HEADACHE. THE HEADACHE WAS REPORTED AS ONGOING AND MEDICATION (UNKNOWN TYPE AND DOSE) WAS ADMINISTERED. ACCORDING TO THE PHYSICIAN, THE HEADACHE WAS POSSIBLY RELATED TO THE PROCEDURE AND TO THE STENT. HOWEVER IT IS UNKNOWN IF THE HEADACHE WAS RELATED TO THE IMPLANTED COILS (SUBJECT DEVICES). AT THE 6 MONTHS FOLLOW-UP THE PATIENT WAS ALSO ASSESSED HAVING A NIHSS AND MRS OF 0. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Headache

  MAUDE report 6864045 ↗