TARGET XL M0036125150Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 07613327128291), received between Dec 5, 2017 and Jul 6, 2026 — classified as 11 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (14 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ANEURYSM RECANALIZATION WAS OBSERVED POST PROCEDURE AND WAS TREATED WITH CLIPPING. THE OUTCOME OF THIS ADVERSE EVENT IS ON GOING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Aneurysm

  MAUDE report 25727448 ↗
• InjuryMar 18, 2026Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE; WHILE ADVANCING THE SUBJECT COIL THROUGH THE MICROCATHETER, THE SUBJECT COIL WAS PARTIALLY DEPLOYED IN THE ANEURYSM AND THEN THE STENT WAS PARTIALLY DEPLOYED. WHEN GOING TO ADVANCE THE REMAINING SUBJECT COIL, IT GOT PREMATURELY DETACHED FROM THE PUSHER WIRE AND THEN THE PHYSICIAN REMOVED THE SUBJECT COIL FROM PATIENT¿S BODY BY USING STENT RETRIEVER. 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 24634383 ↗
• MalfunctionMar 9, 2026Premature Separation

  IT WAS REPORTED THAT WHEN ADVANCING THE SUBJECT COIL WITHIN THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED IN THE SHAFT. THE COIL WAS RETRIEVED WITH THE ENTIRE MICROCATHETER AND FOUND TO BE STRETCHED. IT WAS FOUND THAT THE SUBJECT COIL PREMATURELY DETACHED WITHIN THE MICROCATHETER. 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 24545163 ↗
• InjuryOct 6, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT 139 DAYS POST IMPLANT PROCEDURE, PATIENT EXPERIENCED WITH FOCAL SYMPTOMS. THE ASPRIN AND BRILINTA WERE ADMINISTERED N RESPONSE TO THE ¿FOCAL SYMPTOMS POST IMPLANT. NO OTHER INFORMATION WAS PROVIDED. UPDATE: ADDITIONAL INFORMATION WAS PROVIDED ON 17-OCT-2025 THAT BASED ON PHYSICIAN'S ASSESSMENT, THE FOCAL SYMPTOMS POST IMPLANT WERE LARGELY RELATED TO THE PATIENT'S NONCOMPLIANCE TO THEIR MEDICATION REGIMENT. BECAUSE THERE WAS A CONCERN OF THE INTEGRITY OF THE IMPLANT, AN MAGNETIC RESONANCE ANGIOGRAPHY (MRA) WAS ORDERED AT THE REQUEST OF THE TREATING PHYSICIAN TO ASSESS SAFETY AND INTEGRITY OF THE SUBJECT IMPLANTED COILS AND STENT DUE TO THE PATIENTS¿ MEDICATION NONCOMPLIANCE. AFTER MEETING WITH THE PATIENT, THE TREATING PHYSICIAN DOES NOT BELIEVE THE PATIENTS SYMPTOMS WERE DUE TO THE IMPLANT OR PROCEDURE. THERE WAS NOT TREATMENT IN RESPONSE TO THE REPORTED FOCAL SYMPTOMS POST IMPLANT. THE PATIENT DID NOT SUFFER ANY ADVERSE CONSEQUENCES AS A RESULT OF ¿FOCAL SYMPTOMS POST IMPLANT' . IN PHYSICIAN¿S OPINION THE SUBJECT DEVICE PERFORMED AS INTENDED AND THERE WAS NO ALLEGATION AGAINST THE DEVICE. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT

  Patient problems: Cognitive Changes; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23230058 ↗
• MalfunctionMar 17, 2025Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE THE SUBJECT COIL GOT STUCK IN THE COIL MASS. IT WAS NOT ABLE TO BE DEPLOYED OR REMOVED FROM THE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21625914 ↗
• MalfunctionNov 22, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, DURING DELIVERY THE PHYSICIAN DECIDED TO RE-SHEATH THE SUBJECT COIL, THEN REDELIVER THE SUBJECT COIL INTO THE MICROCATHETER. THE SUBJECT COIL GOT STUCK IN THE DISTAL THIRD OF THE MICROCATHETER AND COULD NOT BE RETRACTED. THE SUBJECT COIL DETACHED WHILST IN THE MICROCATHETER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758289 ↗
• MalfunctionJul 31, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING NEURO ENDOVASCULAR SURGICAL EMBOLIZATION OF BASE OF SKULL/CAVERNOUS SINUS DURAL ARTERIAL VENOUS FISTULA, THE SUBJECT COIL BROKE OFF INSIDE THE PATIENT. PHYSICIAN WAS ABLE TO REMOVE THE SUBJECT COIL IMMEDIATELY AFTER. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19877722 ↗
• InjuryMar 26, 2024Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE THE SUBJECT COIL DETACHED WHILE REPOSITIONING INSIDE THE CATHETER. THE CATHETER HUB WAS CUT AND SNARE DEVICE WAS USED TO REMOVE THE SUBJECT COIL FROM THE CATHETER. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. UPDATE: IT WAS REPORTED DURING THE PROCEDURE THE SUBJECT COIL DETACHED IN THE VESSEL. THE CATHETER HUB WAS CUT AND SNARE DEVICE WAS USED TO REMOVE THE SUBJECT COIL. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18983416 ↗
• InjuryAug 4, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE LEFT ICA (INTERNAL CAROTID ARTERY) TRILOBED ACOMA (ANTERIOR COMMUNICATING ARTERY) PROCEDURE DUE TO TORTUROUS ANATOMY THE SIMULTANEOUS PLACEMENT OF SUPPORT BALLOON AND MICROCATHETER WAS MORE CHALLENGING THAN EXPECTED. THE SUBJECT COIL COULD NOT BE PLACED AND WAS RETRIEVED BY THE OPERATOR. DURING THE SUBJECT COIL RETRIEVAL IT PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE SUBJECT COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. AFTER THE SUBJECT COIL RETRIEVAL, CLOT FORMATION INSIDE THE ANEURYSM WAS OBSERVED, THE PROCEDURE WAS ABANDONED AND THE PATIENT WAS SENT TO SURGICAL CLIPPING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17457022 ↗
• InjuryMar 2, 2023Expulsion; Adverse Event Without Identified Device or Use Problem; Expulsion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT COIL WAS IMPLANTED AND HERNIATED OUT OR THE ANEURYSM POSITION. THEREFORE, THE STENT WAS USED TO RECOVER THE COIL HERNIATED AND COMPLETED THE PROCEDURE. THE PATIENT WAS DISCHARGED POST PROCEDURE DAY 1. THE PATIENT IS CURRENTLY DOING WELL WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. UPDATE ADDITIONAL INFORMATION: THE MDR REPORTS (INITIAL /SUPPLEMENTAL #1- MFR REPORT # 3008881809-2023-00102 ) WERE ORIGINALLY SUBMITTED AS THE TARGET COIL WAS HERNIATED OUTSIDE THE ANEURYSM NECK AND THE STENT WAS USED TO RECOVER THE COILS HERNIATED. RECEIVED ADDITIONAL INFORMATION ON 24-MAY-2024 CONFIRMED THAT THE REPORTED EVENT INVOLVED TO THE STUDY CITADEL COIL. BASED ON THE PHYSICIAN¿S OPINION, THE CITADEL COIL IS USUALLY SUPPOSED TO KEEP THE COIL (TARGET) IN, BUT SOME CASES WHERE IT DOESN'T. THERE WAS NO DEVICE DEFICIENCY TO THE STUDY CITADEL DEVICE. THE STUDY CITADEL DEVICE IS CURRENTLY NOT APPROVED NOR IS IT COMMERCIALLY SOLD IN THE USA; THEREFORE, THIS CITADEL COIL COMPLAINT IS NOT SUBJECT TO MDR REPORTING REGULATION. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENT OF THE REPORTABLE EVENT FOR THE DEVICE IN QU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16469324 ↗
• MalfunctionJan 9, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE IN A PATIENT WITH RUPTURED CEREBRAL ANEURYSM, THE SUBJECT COIL GOT PREMATURELY DETACHED IN THE MICROCATHETER WHILE REPOSITIONING THE SUBJECT COIL TO TRY TO ENGAGE WITH THE ANEURYSM. PREMATURELY DETACHED SUBJECT COIL WAS REMOVED TOGETHER WITH THE ENTIRE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16128078 ↗
• MalfunctionOct 18, 2022Premature Separation; Premature Separation

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT IT PREMATURELY DETACHED DURING USE IN THE PATIENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625247 ↗
• MalfunctionJul 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE THE COIL (SUBJECT DEVICE) BROKE OFF INSIDE THE CATHETER. 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 15070861 ↗
• MalfunctionOct 14, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE THE COIL (SUBJECT DEVICE) DIDN'T DETACH ORIGINALLY EVEN AFTER SEVEN ATTEMPTS USING AN INZONE DETACHMENT SYSTEM, BUT FINALLY THE COIL (SUBJECT DEVICE) DETACHED INSIDE THE CATHETER. THE ANATOMICAL LOCATION WERE THE ISSUE OCCURRED WAS ACOM ¿ANTERIOR COMMUNICATING ARTERY¿. THE PHYSICIAN REPLACED IT WITH A NEW COIL AND CONTINUED THE PROCEDURE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12637202 ↗
• MalfunctionAug 4, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE WHEN THE SUBJECT COIL DEPLOYMENT OPERATION WAS PERFORMED IN THE BLOOD VESSEL, RESISTANCE WAS FELT AT THE MIDDLE PART AND COULD NOT BE USED. THE PHYSICIAN REMOVED THE SUBJECT COIL AND REPLACED IT WITH ANOTHER COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. ANALYSIS OF THE RETURNED DEVICE FOUND THE MAIN COIL PREMATURELY DETACHED/SEPARATED 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 12278609 ↗
• MalfunctionMar 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, COIL EMBOLIZATION WAS PERFORMED USING A MICROCATHETER AND COILS. THE MICROCATHETER WAS GUIDED INTO THE ABDOMINAL BLOOD VESSEL. WHEN THE SUBJECT COIL WAS USED FOR THE 6TH COIL OUT OF THE 11 TOTAL COILS USED, THE SUBJECT COIL WAS STUCK AND WAS NOT ABLE TO BE PUSHED INSIDE THE MICROCATHETER SO IT WAS COLLECTED. AFTER COLLECTION, IT WAS NOTED THAT SUBJECT COIL WAS BROKEN AND WAS DISCARDED. PHYSICIAN COMPLETED THE PROCEDURE SUCCESSFULLY AND NO CLINICAL CONSEQUENCES WERE NOTED TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11545591 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS FILLED AS BEFORE, AND THERE WERE NO PARTICULAR CHANGES, BUT THERE WAS AWARENESS THAT THERE WAS NO 1: 1 MOVEMENT DURING COIL OPERATION. AN ATTEMPT WAS MADE TO COLLECT THE SUBJECT COIL, BUT IT STRETCHED. THE PHYSICIAN MADE AN ATTEMPT TO COLLECT FROM THE SUBJECT COIL FROM THE FEMORAL VESSEL ON THE SAME SIDE AND INSERT THE SNARE FROM THE CONTRALATERAL SIDE. THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11446427 ↗
• InjuryJan 25, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL WAS PREMATURELY DETACHED INSIDE THE MICROCATHETER SHAFT WITHOUT USING THE DETACHMENT SYSTEM; THEREFORE, THE PHYSICIAN HAD TO USE A SNARE DEVICE TO REMOVE THE COIL FROM THE PATIENT ANATOMY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11228247 ↗
• InjuryNov 25, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE PROCEDURE SUBJECT COIL WAS ATTEMPTED TO INSERT. PHYSICIAN THEN NOTED THAT THE SUBJECT DEVICE WAS STRETCHED AND PROCEEDED TO USE A SNARE DEVICE TO REMOVE SUBJECT COIL. 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 10901640 ↗
• MalfunctionOct 7, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE RESISTANCE FELT WHILE INSERTING THE COIL (SUBJECT DEVICE) INTO THE MICROCATHETER AND IT GOT DETACHED INSIDE 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 10640115 ↗
• MalfunctionMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF ACOM UNRUPTURED ANEURYSM, THE SUBJECT COIL STRETCHED WHEN ATTEMPTED TO RE-POSITION. A GOOSENECK SNARE WAS USED TO RETRIEVE THE COIL. THE SUBJECT DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9868281 ↗
• MalfunctionFeb 27, 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 8375594 ↗
• MalfunctionDec 15, 2018Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE,THE COIL DETACHED PREMATURELY INSIDE THE MICROCATHETER. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8167749 ↗
• InjuryOct 19, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING PROCEDURE THE SUBJECT DEVICE WAS STRETCHED AND PROTRUDING FROM THE ANEURYSM. A STENT WAS PLACED TO HOLD THE STRETCHED COIL IN PLACE.THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7987199 ↗
• MalfunctionSep 25, 2018Break; Break

  IT WAS REPORTED THAT WHEN THE COIL (SUBJECT DEVICE) WAS BEING PULLED BACK FOR REPOSITIONING, THE COIL BROKE INSIDE THE MICROCATHETER. THE BROKEN COIL WAS RETRIEVED ALONG WITH THE MICROCATHETER. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7907623 ↗