TARGET XL M0036125100Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327128314), received between Sep 15, 2017 and Dec 4, 2025 — classified as 2 injuries, 8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 23717261 ↗
• MalfunctionDec 9, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL WAS STRETCHED AND PREMATURELY DETACHED INSIDE OF THE MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A FIVE MINUTE SURGICAL DELAY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878159 ↗
• MalfunctionJun 3, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE SUBJECT COIL WAS ADVANCING INSIDE THE CATHETER SHAFT IT GOT STUCK AND DEPLOYED PREMATURELY. THE CATHETER WAS REMOVED AND REPLACED CAUSING A SURGICAL DELAY OF 10 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446224 ↗
• MalfunctionFeb 8, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT SUBJECT COIL COULD NOT BE DETACHED EVEN AFTER SEVERAL ATTEMPTS. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT COIL WAS FOUND TO BE PREMATURELY DETACHED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667730 ↗
• MalfunctionApr 21, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT SUBJECT COIL PREMATURELY DETACHED WHILE BEING ADVANCED IN THE MICROCATHETER. THE SUBJECT COIL WAS REMOVED WITH THE MICROCATHETER FROM THE PATIENT. 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 16783925 ↗
• InjuryDec 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ISCHEMIC STROKE POST-PROCEDURE AT THE RIGHT MCA(MIDDLE CEREBRAL ARTERY) BIFURCATION INFERIOR DIVISION TERRITORY. PER PROGRESS NOTE, SMALL RIGHT-TEMPORAL INFARCTION IS LIKELY ATTRIBUTE TABLE TO RAPID THROMBOSIS OF THE ANEURYSM AND SUBSEQUENT EMBOLIZATION, PRECIPITATED BY PROFOUND POSTOPERATIVE HYPERTENSION. HEPARIN 8000 UNIT IV ONCE WAS ADMINISTERED TO THE PATIENT. THE PATIENT WAS TREATED WITH INTERVENTIONAL RADIOLOGY STROKE THERAPY AND INJECTION OF HEPARIN 4000 UNITS AND 4MG IA TPA UNDER FLUOROSCOPY. THE EVENT OF STROKE IS STILL ONGOING. NO OTHER INFORMATION WAS PROVIDED. BASED ON ADDITIONAL INFORMATION RECEIVED ON 29-DECEMBER-2022 THAT THE PATIENT STROKE POST PROCEDURE WAS CAUSED BY EMBOLIC OCCLUSION OF RIGHT MCA BRANCH. THERE WERE NO ANY DIFFICULTIES ENCOUNTERED DURING THE PROCEDURE THAT COULD HAVE CONTRIBUTED TO THE PATIENT¿S STROKE POST PROCEDURE AS THE SUBJECT COIL PERFORMED AS INTENDED.

  Patient problems: Ischemia Stroke; Obstruction/Occlusion

  MAUDE report 16040274 ↗
• MalfunctionFeb 11, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE IN A PATIENT, THE SUBJECT COIL DETACHED PREMATURELY IN THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518800 ↗
• MalfunctionOct 21, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL WAS ATTEMPTED TO INSERT AS A FRAMING COIL. SUBJECT COILED WAS PUSHED AND PULLED SEVERAL TIMES AND PREMATURELY DETACHED WITHIN THE MICROCATHETER. PHYSICIAN PROCEEDED TO REMOVE THE SUBJECT COIL FROM MICROCATHETER AND EXCHANGED IT WITH A SIMILAR PRODUCT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10713789 ↗
• MalfunctionDec 26, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT WHEN THE COIL WAS REMOVED INTO THE INTRODUCER SHEATH, THE COIL DETACHED PREMATURELY INSIDE THE MICROCATHETER. THE 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 7146968 ↗
• 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 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 6870232 ↗