TARGET XL M0036121240Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04546540711533), received between Dec 27, 2017 and Sep 23, 2026 — classified as 5 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (11 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873847 ↗
• MalfunctionJun 2, 2025Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE THE SUBJECT COIL DETACHED INSIDE THE CATHETER. THE CATHETER AND COIL WERE REMOVED TOGETHER. BOTH DEVICES WERE REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128625 ↗
• InjuryJan 3, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A POSTERIOR ARTERIOVENOUS FISTULA (AVF) CASE, RESISTANCE WAS FELT DURING ADVANCEMENT, AND SUBJECT COIL WAS STRETCHED AND PREMATURELY DETACHED DURING USE. ATTEMPTS WERE MADE TO RETRIEVE THE REMAINING COIL; HOWEVER, IT COULD NOT BE RETRIEVED. THE PROCEDURE WAS COMPLETED AS IT WAS, AND THE PATIENT CONDITION IS NOT KNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 21074167 ↗
• MalfunctionDec 13, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE THE COIL ( SUBJECT DEVICE) PREMATURELY DETACHED WITHIN THE CATHETER. 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 18321163 ↗
• MalfunctionNov 14, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE WHEN THE SUBJECT COIL WAS DEPLOYED ABOUT FOUR OR FIVE LOOPS IN THE VESSEL, IT WAS RETRACTED TO REPOSITION. WHILE DOING SO THE SUBJECT COIL GOT PREMATURELY DETACHED AND MORE THAN 20CM OF SUBJECT COIL REMAINED IN THE MICROCATHETER. THEREFORE THE SUBJECT COIL ALONG WITH THE MICROCATHETER WAS REMOVED FROM THE PATIENT'S BODY. 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 18129918 ↗
• MalfunctionOct 11, 2022Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE THAT WHEN THE SUBJECT COIL WAS REPOSITIONED, IT PREMATURELY DETACHED INSIDE THE CATHETER WHILE RETRACTING. THE PHYSICIAN REPLACED BOTH DEVICES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581177 ↗
• InjuryFeb 22, 2022Fracture; Expulsion; Fracture; Expulsion

  IT WAS REPORTED THAT POST TWO ATLAS STENT PLACEMENTS IN A Y CONFIGURATION (ONE FROM L ACA ¿ANTERIOR CEREBRAL ARTERY¿ TO ICA ¿INTERNAL CAROTID ARTERY¿ AND ONE FROM L MCA ¿MIDDLE CEREBRAL ARTERY¿ TO ICA ¿INTERNAL CAROTID ARTERY¿), DOCTOR BEGAN COILING THE ANEURYSM THROUGH A JAILED SL-10 45 MICROCATHETER. DURING HIS FOURTH COIL DEPLOYMENT, WHEN THE DOCTOR WAS TRYING TO REPOSITION THE COIL (SUBJECT DEVICE) IT GOT STUCK AND WOULDN¿T ADVANCE INTO THE ANEURYSM OR PULL BACK OUT OF THE ANEURYSM. THE DOCTOR ASSUMED AT THIS POINT THAT THE COIL (SUBJECT DEVICE) FRACTURED AND BROKE. THE COIL (SUBJECT DEVICE) WAS PARTIALLY IN THE ANEURYSM AND PARTIALLY OUT OF THE ANEURYSM. THE COIL (SUBJECT DEVICE) WAS NEVER ATTEMPTED TO BE DETACHED. AT THE SAME TIME, THERE WAS THROMBUS FORMATION. USED GOOSE NECK SNARE AS MEDICAL INTERVENTION TO RETRIEVE ANY PORTION OF THE COIL (SUBJECT DEVICE) BUT IT WAS UNSUCCESSFUL. NO ONE WAS ABLE TO IDENTIFY EXACTLY WHERE THE COIL (SUBJECT DEVICE) BREAK OCCURRED. THIRD ATLAS STENT WAS THEN PLACED PROXIMAL TO THE Y STENTS IN THE (ICA) INTERNAL CAROTID ARTERY TO TACK THE COIL (SUBJECT DEVICE) TAIL AGAINST THE (ICA) INTERNAL CAROTID ARTERY VESSEL WALL AS MEDICAL INTERVENTION.

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 13579050 ↗
• MalfunctionOct 7, 2021Premature Separation; Premature Separation

  ANALYSIS OF THE DEVICE REVEALED THAT THE MAIN COIL PREMATURELY DETACHED/SEPARATED DURING USE. THERE WAS NO MEDICAL CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12595498 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, PHYSICIAN WAS PLACING THE SUBJECT COIL AND WHILE REPOSITIONING, IT GOT TANGLED WITH THE COILS ALREADY PLACED IN THE ANEURYSM AND GOT STRETCHED. PHYSICIAN TRIED TO REMOVE THE WHOLE SETUP BUT THE MICROCATHETER WAS ALSO STRETCHED AND ULTIMATELY PHYSICIAN USED A SNARE DEVICE TO REMOVE THE SUBJECT COIL. 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 12199829 ↗
• MalfunctionMay 17, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A PROCEDURE IN THE LEFT ANTERIOR COMMUNICATING ARTERY, THE PHYSICIAN SUCCESSFULLY CATHETERIZED THE ANEURYSM WITH A MICRO CATHETER. THE GUIDE WIRE WAS RETRACTED AND THE FIRST COIL WAS LOADED INTO THE MICRO CATHETER, BUT AFTER ADVANCING APPROXIMATELY ONE OR TWO THIRDS IN THE MICROCATHETER SHAFT, IT GOT STUCK IN THE MICRO CATHETER. WHEN THE PHYSICIAN TRIED TO PULL BACK THE FIRST COIL, IT DETACHED IN THE MICRO CATHETER AND BOTH DEVICES WERE REMOVED AND REPLACED WITH SIMILAR DEVICES. THE SAME EVENT HAPPENED WITH THE SECOND SUBJECT COIL AND MICRO CATHETER AND THE PHYSICIAN REMOVED AND REPLACED THEM WITH A THIRD SET OF REPLACEMENT DEVICES WHICH ALSO HAD THE SAME EVENT HAPPEN. THIS CAUSED A 30 MINUTE SURGICAL DELAY. THE PHYSICIAN REMOVED THEM AND REPLACED WITH SIMILAR DEVICES TO COMPLETE THE PROCEDURE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832972 ↗
• MalfunctionJun 9, 2020Premature Separation; Premature Separation

  THE REVIEW OF THE INVESTIGATION OF THE RETURNED PRODUCT FOUND THE COIL PREMATURELY DETACHED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10133683 ↗
• MalfunctionDec 5, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL PREMATURELY DETACHED WITHIN THE (NON-STRYKER) CATHETER INSIDE THE PATIENT. THE COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENTS MEDICAL CONDITION WAS GOOD. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9420615 ↗
• MalfunctionApr 9, 2019Break; Break

  REVIEW OF THE INVESTIGATION OF THE RETURNED PRODUCT REVEALED THAT THE MAIN COIL WAS BROKEN. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8497739 ↗
• MalfunctionOct 19, 2018Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT DEVICE PREMATURELY DEPLOYED INSIDE THE CATHETER. PER PHYSICIAN¿S OPINION MAY HAVE BEEN CAUSED BY FRICTION INSIDE THE CATHETER. ADDITIONALLY,THE FRICTION WAS OBSERVED WHILE ADVANCING THE SUBJECT DEVICE THROUGH STENT AND THE SUBJECT DEVICE DEPLOYED WHEN IT WAS PULLED BACK. THE SUBJECT DEVICE AND THE MICROCATHETER WERE SAFELY REMOVED FROM THE PATIENT AS ONE UNIT AND THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7987197 ↗
• InjuryOct 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MAIN COIL (SUBJECT DEVICE) STRETCHED. THE STRETCHED COIL WAS REMOVED FROM THE PATIENT USING A GOOSE NECK SNARE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7936754 ↗
• InjuryApr 30, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THE COIL PREMATURELY DETACHED AND THE PHYSICIAN HAD TO USE A LASSO SNARE TO RETRIEVE THE COIL FROM THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7473537 ↗
• MalfunctionDec 27, 2017Break; Break

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE WITH A COIL (SUBJECT DEVICE), THE COIL BROKE OFF INSIDE THE MICROCATHETER. THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7148263 ↗