TARGET XL M0036126200Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 07613327004625), received between Aug 18, 2016 and Jun 4, 2026 — classified as 12 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (12 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT COIL WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25398353 ↗
• MalfunctionFeb 24, 2026Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SUBJECT MAIN COIL HAD APPEARED TO BE BROKEN/FRACTURED. THE SUBJECT DEVICE WAS REPLACED, AND 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 24430760 ↗
• MalfunctionDec 4, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT COIL GOT SELF-DETACHED IN THE MICROCATHETER. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716803 ↗
• MalfunctionAug 12, 2025Fracture; Premature Separation; Fracture; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE MAIN COIL (SUBJECT DEVICE) WAS DETACHED WITHIN THE MICROCATHETER, AND THE MAIN COIL WAS FOUND TO BE SEVERELY DAMAGED. THE COIL WAS STRETCHED, HAD SUTURE DAMAGE 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 DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784015 ↗
• MalfunctionApr 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE INTERNAL ILIAC ARTERY EMBOLIZATION PROCEDURE, THE SUBJECT COIL WAS FOUND TO BE BROKEN UPON ITS RETRIEVAL. THE SUBJECT DEVICE WAS REPLACED, AND 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 21911101 ↗
• MalfunctionJan 8, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION IN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE, THE SUBJECT COIL ENCOUNTERED RESISTANCE INSIDE THE MICROCATHETER'S SHAFT AND PREMATURELY DETACHED INSIDE OF THE MICROCATHETER DURING REPOSITIONING. THE SUBJECT DEVICE WAS REPLACED, AND 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 21106512 ↗
• MalfunctionSep 18, 2024Fracture; Premature Separation; Fracture; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE COIL (SUBJECT DEVICE) FOUND TO HAVE PREMATURELY DETACHED OR SEPARATED. A PORTION OF THE COIL THAT WAS REMOVED FROM THE MICROCATHETER WAS FOUND TO BE FRACTURED. THE SUBJECT DEVICE WAS REPLACED, AND 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 20251827 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BEYOND 48 HOURS POST PROCEDURE, THE ANEURYSM REGROWTH WAS OBSERVED WHICH REQUIRED TREATMENT. PER PHYSICIAN¿S OPINION, THE REASON FOR THE RECANALIZATION OF ANEURYSMS WAS COIL COMPACTION. ACCORDING TO THE SITE, THE RELATIONSHIP OF THE ADVERSE EVERT 'ANEURYSM REGROWTH' PROBABLY RELATED TO THE SUBJECT DEVICE, STUDY DISEASE AND PRE-EXISTING CONDITION/CO-MORBIDITY. THE PATIENT¿S CURRENT CONDITION IS STABLE, NEUROLOGIC BASELINE.

  Patient problems: Aneurysm

  MAUDE report 19767375 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON OCCLUSIVE THROMBUS OCCURRED ON (B)(6) 2024 POST PROCEDURE BEFORE DISCHARGE AS THE PATIENT EXPERIENCED ONSET OF SLURRED SPEECH AND RIGHT SIDED GRIP WEAKNESS. THE OUTCOME OF THE ADVERSE EVENT WAS RESOLVED, WITHOUT SEQUELAE ON THE SAME DAY. ACCORDING TO THE SITE, THE ADVERSE EVENT WAS POSSIBLY RELATED TO THE NON STUDY SUBJECT DEVICE AND STUDY DISEASE; AND CAUSALLY RELATED TO THE INDEX PROCEDURE. MEDICATIONS WERE PROVIDED TO TREAT THE ADVERSE EVENT

  Patient problems: Muscle Weakness/Atrophy; Speech Disorder; Thrombosis/Thrombus

  MAUDE report 19367024 ↗
• MalfunctionFeb 6, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE, WHEN THE SUBJECT COIL WAS DEPLOYED FROM THE MICROCATHETER AND WAS BEING REPOSITIONED SEVERAL TIMES, THE SUBJECT COIL WAS PREMATURELY DETACHED FROM THE DELIVERY WIRE WITHOUT USING INZONE. THE COIL WAS REMOVED WITH THE ENTIRE MICROCATHETER AND REPLACED WITH A NEW ONE 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 18655981 ↗
• MalfunctionSep 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL WAS BROKEN. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17795999 ↗
• MalfunctionMar 24, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE WITH A DOUBLE CATHETER TECHNIQUE, THE PHYSICIAN PLACED TWO COILS INTO THE ANEURYSM AND ATTEMPTED TO DETACH THE COIL WITH THE DETACHMENT SYSTEM. HOWEVER, ONE OF THE COILS WAS DETACHED INTO THE ANEURYSM, BUT THE DETACHMENT SYSTEM WAS NOT ABLE TO DETECT THE SUBJECT COIL DELIVERY WIRE AND COULD NOT BE DETACHED INTO THE ANEURYSM. THE PHYSICIAN REPLACED THE DETACHMENT SYSTEM WITH ANOTHER ONE AND ATTEMPTED TO DETACH THE SUBJECT COIL, BUT STILL, THE ISSUE REMAINS. ON WITHDRAWING THE SUBJECT COIL FROM THE PATIENT'S ANATOMY, RESISTANCE WAS FELT INSIDE THE MICROCATHETER DUE TO THIS THE SUBJECT COIL WAS PREMATURELY DETACHED INSIDE THE MICROCATHETER. FURTHER, THE PHYSICIAN PUSHED THE SUBJECT COIL INTO THE ANEURYSM BY THE DELIVERY WIRE. 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 13873573 ↗
• InjuryFeb 7, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT A COIL EMBOLIZATION PROCEDURE WAS PERFORMED IN INTERNAL ILIAC ARTERY, IN A PATIENT. DURING THE PROCEDURE THE SUBJECT COIL WAS PUSHED AND PULLED SEVERAL TIMES INSIDE THE LUMEN OF THE MICROCATHETER AND THE SUBJECT COIL WAS PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE DETACHED SUBJECT COIL WAS REMOVED OUT OF THE PATIENT VASCULAR ANATOMY AND RETRIEVED WITH A SNARE DEVICE. THE PROCEDURE WAS COMPLETED AND NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472300 ↗
• MalfunctionAug 9, 2021Fracture; Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT MAIN COIL WAS BROKEN/FRACTURED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12298542 ↗
• InjuryJul 2, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A PROCEDURE OF COILING A BRAIN ANEURYSM, WHEN THE PHYSICIAN WAS ADVANCING THE SUBJECT COIL, IT PREMATURELY DETACHED IN THE MICROCATHETER. THE PHYSICIAN REMOVED THE SUBJECT MICROCATHETER AND USED A SNARE AND COMPLETED THE PROCEDURE SUCCESSFULLY AND NO CLINICAL CONSEQUENCES WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12105705 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Premature Separation; Adverse Event Without Identified Device or Use Problem; Premature Separation

  IT WAS REPORTED THAT DURING THE EMBOLIZATION PROCEDURE THE SUBJECT COIL GOT STRETCHED WHILE FILING INSIDE THE PATIENT¿S ANATOMY. THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE SUBJECT COIL THEREFORE, A SNARE DEVICE WAS USED TO COLLECT THE SUBJECT COIL OUT OF THE PATIENT¿S ANATOMY. 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 11778459 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE EMBOLIZATION PROCEDURE THE SUBJECT COIL GOT STRETCHED WHILE FILING INSIDE THE PATIENT¿S ANATOMY. THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE SUBJECT COIL THEREFORE, A SNARE DEVICE WAS USED TO COLLECT THE SUBJECT COIL OUT OF THE PATIENT¿S ANATOMY. 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 11778386 ↗
• InjuryMar 24, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT WHEN THE SUBJECT COIL WAS EMBOLIZED, BLOOD FLOW WAS STAGNANT DUE TO DEVIATION/MIGRATION OF THE SUBJECT COIL LOOP FROM ANEURYSM TO MOTHER BLOOD VESSEL AND ADHESION OF THROMBUS OCCURRED. THEREFORE, THE STENT WAS IMPLANTED AT THE A-COM. AT THAT TIME, AN UNKNOWN GUIDEWIRE WAS INSERTED TO REMOVE THE CATHETER AND COLLECTED TOGETHER. WHEN AN UNKNOWN GUIDEWIRE WAS REMOVED, THE COATING OF THE UNKNOWN GUIDEWIRE APPEARED ON THE LUMEN OF THE CATHETER. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11564793 ↗
• InjuryFeb 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FIRST SUBJECT COIL WAS USED TO CREATE A FRAME IN THE TARGET SITE. WITHOUT DETACHING THE FIRST COIL, THE PHYSICIAN THEN PLACED 5 TO 6 COILS TO THE TARGET SITE. THE PHYSICIAN TRIED TO DETACH THE SUBJECT COIL ONCE THE FRAMING WAS STABLE; HOWEVER, THE COIL WAS NOT ABLE TO BE DETACHED. THE DETACHMENT SYSTEM WAS REPLACED, BUT STILL THE COIL COULD NOT BE DETACHED. TO REMOVE THE COIL FROM THE PATIENT¿S ANATOMY, THE PHYSICIAN COLLECTED THE SUBJECT COIL WHILE HOLDING IT WITH THE BALLOON CATHETER DURING THIS TIME THE COIL BECAME STRETCHED AND A GOOSENECK SNARE WAS USED TO REMOVE IT FROM THE PATIENT¿S ANATOMY. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11266785 ↗
• MalfunctionSep 25, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE COIL (SUBJECT DEVICE) WAS DETACHED PREMATURELY IN THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENTS MEDICAL CONDITION WAS GOOD. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10590544 ↗
• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIED TO ADVANCE A COIL (SUBJECT DEVICE), THE COIL GOT STUCK AROUND THE STRUCT OF A STENT. THE PHYSICIAN TRIED TO REMOVE THE COIL FROM THE SUBJECT STENT BUT WAS NOT SUCCESSFUL; THEREFORE, TWO STENTS WERE DEPLOYED TO FIX THE COIL AND THE COIL WAS DETACHED. DURING THE PROCEDURE, THE PATIENT DEVELOPED THROMBOSIS IN THE LEFT P1. THE PHYSICIAN TRIED REMOVE THE THROMBUS, BUT THE PROCEDURE WAS CEASED AS THE BLOOD FLOW RECOVERED. THE PATIENT IS UNDER ADDITIONAL TREATMENT TO TREAT THE REMAINING BLOOD CLOT IN THE P1. THE PATIENT IS RECOVERED AND STABLE NOW.

  Patient problems: Foreign Body In Patient; Thrombosis

  MAUDE report 10156083 ↗
• MalfunctionMay 22, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED INSIDE THE CATHETER. THE COIL WAS REMOVED AND THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10083829 ↗
• MalfunctionMay 29, 2019Break; Break

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL WAS BROKEN/FRACTURED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8651751 ↗
• MalfunctionMar 13, 2019Break; Break

  DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REVEALED THAT THE COIL DELIVERY WIRE WAS BROKEN INSIDE THE PATIENT. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8419058 ↗
• InjuryFeb 26, 2019Premature Separation; Premature Separation

  DURING THE COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE COIL WAS PREMATURELY DETACHED IN THE MICROCATHETER INSIDE THE PATIENT DURING REPOSITION. THEREFORE, THE COIL WAS REMOVED WITH SNARE. THEN THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER CHANGING THE COIL. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8370608 ↗