TARGET XL M0036123060Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327128277), received between Jul 20, 2016 and Feb 15, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (7 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.

• MalfunctionFeb 15, 2026Premature Separation

  IT WAS REPORTED THAT DURING A HAEMOSTATIC EMBOLISATION PROCEDURE, REPEATED ATTEMPTS WERE MADE TO REPOSITION THE SUBJECT COIL TIGHTLY BY REWINDING IT. HOWEVER, IT WAS CONFIRMED UNDER FLUOROSCOPY THAT THE SUBJECT COIL WOULD NOT ADVANCE WHEN PULLED AND IT SEEMED THAT THE SUBJECT COIL GOT PREMATURELY DETACHED WITHIN 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 24341620 ↗
• MalfunctionNov 14, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING REPOSITIONING OF THE SUBJECT COILS IN THE ANEURYSM, THE SUBJECT COILS STOPPED MOVING. THE OPERATOR CONCLUDED THAT THE SUBJECT COILS WERE TANGLED AND ATTEMPTED TO RETRIEVE THEM. HOWEVER, THE SUBJECT COILS GOT STRETCHED AND COULD NOT BE RETRACTED. THEY WERE DETACHED BY TORQUE AND REMAINING PART OF THE SUBJECT COILS WAS FLUSHED INTO THE ANEURYSM. 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 20685228 ↗
• MalfunctionMay 2, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE SUBJECT COIL WITHIN THE MICROCATHETER SHAFT. WHILE RETRIEVING, THE SUBJECT COIL DETACHED PREMATURELY WITHIN THE MICROCATHETER. 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 19235106 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE FOR A RUPTURED ANEURYSM, PHYSICIAN USED THE SUBJECT COIL AND FLOW DIVERTING STENT TO TREAT THE PATIENT. POST PROCEDURE ON (B)(6) 2023, PATIENT WAS READMITTED DUE TO FINE MOTOR DISTURBANCE OF RIGHT HAND SINCE 16TH MAY, FACIALIS WEAKNESS ON RIGHT HAND. MULTIFOCAL SUBCORTICAL EDEMA WAS NOTICE IN THE CT (COMPUTED TOMOGRAPHY) AND MRI (MAGNETIC RESONANCE IMAGING). ACCORDING THE THE PHYSICIAN IT IS CAUSED BY CONTACT ALLERGY (NEW) TYPE IV TO NICKEL + COBALT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Cerebral Edema; Neuropathy

  MAUDE report 17326929 ↗
• MalfunctionJun 13, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE IN A PATIENT WITH GASTROINTESTINAL BLEEDING, THERE WAS RESISTANCE WHEN THE SUBJECT COIL WAS ADVANCED THROUGH THE INTRODUCER SHEATH AND AFTER INSERTING AND RETRACTING THREE TIMES, THE SUBJECT COIL DETACHED PREMATURELY INSIDE THE MICROCATHETER. THE DETACHED SUBJECT COIL WAS REMOVED FROM PATIENT VASCULATURE TOGETHER WITH THE MICROCATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14680398 ↗
• MalfunctionJan 8, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT WHEN THE COIL (SUBJECT DEVICE) DETACHED PREMATURELY INSIDE THE MICROCATHETER. THE COIL WAS EXCHANGED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9567142 ↗
• MalfunctionSep 4, 2019Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL WAS PREMATURELY DETACHED/SEPARATED INSIDE PATIENT. NO KNOWN CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8962659 ↗
• MalfunctionJul 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT SUCCESSFULLY UNDERWENT COIL EMBOLIZATION FOR AN ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH 4 COILS (SUBJECT DEVICE) AND A MICROCATHETER. NEXT DAY MAGNETIC RESONANCE IMAGING (MRI) SHOWED AN ARTIFACT. THE CT IMAGE SHOWED NO SIGN. ACCORDING TO THE PHYSICIAN, THE ARTIFACT MAY BE A MARKER FOR THE PRODUCT USED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8788856 ↗
• MalfunctionDec 17, 2018Premature Separation; Premature Separation

  DURING THE COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE COIL IN THE MICROCATHETER AND THE COIL WAS PREMATURELY DETACHED INSIDE THE MICROCATHETER DURING ADVANCEMENT. THEREFORE, THE COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER CHANGING TO A NEW COIL. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8171932 ↗
• MalfunctionJul 30, 2018Break; Break

  ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE COIL DELIVERY WIRE WAS BROKEN. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7733565 ↗
• InjuryJul 20, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 6 MONTHS POST STENT-ASSISTED COIL EMBOLIZATION OF THE RIGHT MIDDLE CEREBRAL ARTERY BIFURCATION ANEURYSM, MODERATE COIL COMPACTION OCCURRED. RE-INTERVENTION FOR RESIDUAL FILLING OF THE TARGET ANEURYSM WAS NECESSARY. THE PROCEDURE WAS RESOLVED WITHOUT RESIDUAL EFFECTS. THE PHYSICIAN OPINION IS THAT THE ADVERSE EVENT IS RELATED TO THE PROCEDURE AND TO THE COILS (ONE TARGET COIL AND SEVERAL NON-STRYKER COILS).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5809160 ↗