TARGET XL M0036123090Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07613327128284), received between Jun 6, 2016 and May 28, 2026 — classified as 4 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DETACHMENT OF THE SUBJECT COIL WAS ATTEMPTED MORE THAN 10 TIMES USING THE POWER SUPPLY, BUT WAS UNSUCCESSFUL. BECAUSE DETACHMENT COULD NOT BE ACHIEVED, THE SUBJECT COIL RETRIEVAL WAS ATTEMPTED, DURING WHICH AN ANEURYSM RUPTURE OCCURRED. THE SUBJECT COIL STRETCHED DURING RETRIEVAL AND WAS SUBSEQUENTLY REMOVED USING A SNARE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE PATIENT IS STABLE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 25323308 ↗
• MalfunctionNov 17, 2025Premature Separation; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE AND WAS REPORTED FOR BEING UNABLE TO DETACH. HOWEVER, WHEN THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS, IT WAS DISCOVERED THAT THE COIL DELIVERY WAS KINKED AND THE MAIN COIL WAS PREMATURELY DETACHED/SEPARATED 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 23575821 ↗
• MalfunctionJun 3, 2025Premature Separation; Premature Separation

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT COIL WAS PREMATURELY DETACHED/SEPARATED 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 22137407 ↗
• MalfunctionMar 19, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE INFERIOR MESENTERIC ARTERY (IMA) EMBOLIZATION IN A TYPE-II ENDO LOCK (EL) CASE, THE SUBJECT COIL ENCOUNTERED RESISTANCE WHILE ADVANCING THROUGH THE MICROCATHETER AND GOT STUCK. WHEN THE SUBJECT COIL WAS PULLED BACK, THE MIDDLE SECTION OF SUBJECT MAIN COIL GOT STRETCHED AND IT WAS PREMATURELY SEPARATED/DETACHED FROM THE SUBJECT COIL DELIVERY WIRE INSIDE THE MICROCATHETER. THE PROCEDURE WAS ALMOST COMPLETE, SO IT WAS FINISHED WITHOUT ADDITIONAL EMBOLIZATION. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642866 ↗
• MalfunctionAug 6, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE THE OPERATOR PLACED THE MICROCATHETER TO THE LOCATION. NEXT, THE OPERATOR DELIVERED THE SUBJECT COIL AND DURING COIL REPOSITIONING IT DETACHED PREMATURELY. 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 19924429 ↗
• MalfunctionApr 29, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN USING THE FOURTH OF SIX COILS, IT WAS OBSERVED THAT THE SUBJECT COIL WOULD NOT ADVANCE DESPITE MULTIPLE ATTEMPTS. WHEN ATTEMPTING TO PULL IT BACK, THE SUBJECT COIL WOULD NOT RETRACT. AFTER REMOVING THE DELIVERY WIRE, A VISUAL INSPECTION SHOWED THAT THE SUBJECT COIL HAD DETACHED PREMATURELY. THE SUBJECT COIL 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 19210347 ↗
• MalfunctionJan 4, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT A COIL EMBOLIZATION PROCEDURE WAS PERFORMED IN A PATIENT. WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE SUBJECT COIL THROUGH A MICROCATHETER, THE SUBJECT COIL DETACHED PREMATURELY INSIDE THE MICROCATHETER LUMEN. THE SUBJECT COIL WAS REPLACED WITH ANOTHER DEVICE 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 13155604 ↗
• InjuryAug 16, 2021Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED IN THE CATHETER. THE DEVICE WAS REMOVED WITH A SNARE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12325413 ↗
• MalfunctionAug 2, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE EMBOLIZATION, FIRST COIL WAS SUCCESSFULLY ADVANCED USING A MICROCATHETER. HOWEVER, WHEN ADVANCING THE SECOND COIL, RESISTANCE WAS NOTED AT THE HUB OF THE MICROCATHETER. WHEN THE COIL WAS REMOVED, STRETCH WAS NOTED AND THE COIL WAS REPLACED WITH A NEW COIL. THIS COIL ALSO EXPERIENCED FRICTION AT THE HUB OF THE MICROCATHETER AND WAS STUCK INSIDE THE SHAFT OF THE MICROCATHETER. BOTH COIL AND THE MICROCATHETER WERE REMOVED FROM THE PATIENT'S ANATOMY. THE PHYSICIAN REPLACED THE MICROCATHETER AND USED IT TO DELIVER THE SUBJECT COIL. FRICTION WAS ALSO REPORTED AT THE HUB AND INSIDE THE MICROCATHETER WHEN ADVANCING THE SUBJECT COIL. DURING REMOVAL OF THE SUBJECT COIL, IT PREMATURELY DETACHED INSIDE THE MICROCATHETER. 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 12262858 ↗
• MalfunctionJul 23, 2021Fracture; Fracture

  IT WAS INITIALLY REPORTED THAT DURING THE REPOSITIONING THE COIL INTO THE ANEURYSM, STRETCHED WAS NOTED AT THE MAIN COIL. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT MAIN COIL WAS KINKED AND THE COIL DELIVERY WIRE 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 12221943 ↗
• MalfunctionJul 24, 2020Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE PROCEDURE, PHYSICIAN NOTED RESISTANCE WHEN INSERTING INITIAL COIL THROUGH MICROCATHETER. PHYSICIAN MANAGED TO DETAIN COIL BUT WAS UNABLE TO DETACH COIL WITH DETACHMENT SYSTEM. PRODUCT WAS REPLACED WITH SUBJECT COIL AND RESISTANCE WAS MET WITHIN MICROCATHETER. UPON WITHDRAWAL SUBJECT COIL WAS NOTED TO BE STRETCHED BY THE PHYSICIAN. SUBJECT COIL WAS REPLACED AND PROCEDURE CONTINUED SUCCESSFULLY WITHOUT CLINICAL CONSEQUENCE TO THE PATIENT. ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE SUBJECT COIL HAD FRACTURED DURING USE. THEREFORE, THIS EVENT MEETS REPORTING CRITERIA WITH AN AWARENESS DATE OF 30-JUN-2020. THE EVENT WILL BE ASSESSED TO REFLECT THE DECISION CHANGE AND EMDR WILL BE FILED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10323841 ↗
• MalfunctionMar 23, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL WAS PREMATURELY DETACHED WHILE BEING ADVANCED INSIDE THE MICRO CATHETER DURING PROCEDURE. THE PHYSICIAN USED MICRO CATHETER AND GUIDE WIRE TO PLACE THE SUBJECT COIL AND COMPLETED THE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9868075 ↗
• MalfunctionDec 3, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL WAS UNABLE TO BE DETACHED BY THE POWER SUPPLY AND AFTER THREE ATTEMPTS, THE PHYSICIAN TRIED TO REMOVE THE SUBJECT COIL FROM THE MICRO CATHETER, BUT THE COIL GOT STUCK INSIDE THE MICRO CATHETER. THE PHYSICIAN THEN RETRIEVED THE SUBJECT COIL ALONG WITH THE MICRO CATHETER AND THE COIL WAS FOUND PREMATURELY DETACHED INSIDE THE MICRO CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9406908 ↗
• MalfunctionNov 21, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE COIL (SUBJECT DEVICE) WAS UNABLE TO ADVANCE INSIDE THE MICROCATHETER (NON-STRYKER DEVICE). DURING RETRACTION, RESISTANCE WAS FELT TOO, AND THE COIL BROKE/SEPARATED WITHIN THE MICROCATHETER. UPON REMOVAL OUT OF THE BODY, FRACTURED MAIN COIL WAS FOUND STRETCHED. THE COIL AND MICROCATHETER WERE REPLACED AND THE PROCEDURE COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9359795 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE MAIN COIL (SUBJECT DEVICE) WAS STUCK AT THE DISTAL PORTION OF THE MICROCATHETER. THE PHYSICIAN TRIED TO RETRIEVED BY APPLYING NEGATIVE PRESSURE WITH A SYRINGE, BUT THE COIL COULD NOT BE REMOVED. AFTER THAT, IT WAS CAUGHT WITH SNARE AND RETRIEVED WITH MICROCATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE ARE NO KNOWN CLINICAL CONSEQUENCES TO THE PATIENT AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8942791 ↗
• InjuryJan 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, THE SUBJECT COIL WAS STRETCHED AND PERFORATED THE ANEURYSM. NO KNOWN CLINICAL IMPACT TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 8209552 ↗
• MalfunctionFeb 19, 2017Premature Activation; Premature Activation

  ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE MAIN COIL HAD PREMATURELY DETACHED/SEPARATED. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6342596 ↗
• MalfunctionJun 14, 2016Premature Activation; Premature Activation

  THE PHYSICIAN UNSUCCESSFULLY REPOSITIONED THE COIL SEVERAL TIMES; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT WHEN THE COIL WAS BEING REMOVED IT BECAME STUCK IN THE Y-CONNECTOR VALVE AND IT DETACHED. THERE WAS NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5723126 ↗
• MalfunctionJun 9, 2016Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION, WHEN THE COIL WAS REPOSITIONED SEVERAL TIMES IN THE ANEURYSM, THE COIL WAS STRETCHED AND BROKE OFF. THE DISTAL SIDE OF THE COIL WAS DEPLOYED IN THE ANEURYSM AND THE STRETCHED PART OF THE COIL WAS PROTRUDED FROM THE ANEURYSM. THE MICROCATHETER WAS FLUSHED TO PUSH THE PROTRUDING PART OF THE COIL INTO THE ANEURYSM. THE PROXIMAL SIDE OF THE COIL WAS ABLE TO BE RETRIEVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5709141 ↗
• MalfunctionJun 6, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF AN ANEURYSM OF THE BRONCHIAL ARTERY, THE MAIN COIL WAS REPOSITIONED SEVERAL TIMES. WHEN THE COIL WAS REINSERTED INTO THE MICROCATHETER, RESISTANCE WAS EXPERIENCED. AS A RESULT, IT WAS DECIDED TO RETRIEVE THE COIL. IN THE PROCESS OF RETRIEVING THE COIL, THE COIL PREMATURELY DETACHED AT THE DETACHMENT ZONE WITHIN THE MICROCATHETER. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5701109 ↗