TARGET XL M0036124120Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07613327128338), received between Jul 6, 2016 and Aug 6, 2026 — classified as 8 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (9 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Premature Separation

  It was reported that the subject coil got stuck and detached inside the microcatheter. The subject device was removed, 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 50167285 ↗
• MalfunctionSep 16, 2025Fracture; Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE MAIN COIL (SUBJECT DEVICE) HAD SUTURE DAMAGE, WAS STRETCHED AND BROKEN/FRACTURED DURING USE. ALSO, THE COIL DELIVERY WIRE WAS KINKED/BENT. 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 23061763 ↗
• InjuryJun 30, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF SUBARACHNOID HEMORRHAGE (SAH) PROCEDURE, THE OPERATOR IMPLANTED SIX COILS USING A GUIDEWIRE AND A MICROCATHETER. THE SUBJECT COIL WAS ATTEMPTED TO BE PLACED AS THE SEVENTH COIL; HOWEVER, WHILE REPOSITIONING, THE SUBJECT COIL COULD NOT TO BE MOVED AS INTENDED. THE OPERATOR ATTEMPTED TO RETRIEVE THE SUBJECT COIL, WHICH CAUSED A PREMATURE DETACHMENT. THE SUBJECT COIL WAS REMOVED USING A GOOSE NECK SNARE. UPON RETRIEVAL, THE SUBJECT COIL WAS FOUND TO BE STRETCHED. 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 22359755 ↗
• InjuryJan 28, 2025Expulsion; Expulsion

  IT WAS REPORTED THAT THE INDEX PROCEDURE ON (B)(6) 2024 WAS COMPLETED SUCCESSFULLY AS THE SUBJECT COIL WAS SUCCESSFULLY DELIVERED INTO THE TARGET ANEURYSM AS INTENDED. HOWEVER, AT THE END OF THE PROCEDURE, THE SUBJECT COIL WAS POPPED OUT, THEREFORE, THE BALLOON WAS USED TO MOVE THE SUBJECT COIL BACK INTO ANEURYSM. THEN THE STENT WAS USED TO HOLD THE SUBJECT COIL IN PLACE. PER PHYSICIAN¿S OPINION OF THE SUBJECT COIL POPPED OUT WAS CAUSED BY OVERSIZING OF THE SUBJECT COIL. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THE EVENT. POST PROCEDURE TARGET ANEURYSM STATUS RAYMOND SCORE OF 2 - RESIDUAL NECK/DOG EAR DEFINED AS THE PERSISTENCE OF ANY PORTION OF THE ORIGINAL DEFECT OF THE ARTERIAL WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21253769 ↗
• MalfunctionMar 26, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN EMERGENCY COIL EMBOLIZATION TO ADDRESS ABDOMINAL BLEEDING. THREE COILS WERE PLACED. WHEN ATTEMPTING TO PLACE THE FOURTH COIL (SUBJECT DEVICE), RESISTANCE WAS ENCOUNTERED IN THE THE SHAFT OF THE MICROCATHETER. WHEN RETRACTING THE SUBJECT COIL, IT DETACHED PREMATURELY INSIDE THE MICROCATHETER. THE SUBJECT COIL AND THE MICROCATHETER WERE RETRIEVED TOGETHER AND THE SUBJECT COIL WAS REPLACED. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME MICROCATHETER. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18980909 ↗
• MalfunctionJan 16, 2024

  THE STRYKER COIL WOULD NOT ADVANCE IN THE CATHETER. MANY COILS WERE USED, AND ALL OTHERS WERE SUCCESSFULLY FUNCTIONING. THIS COIL WAS MALFUNCTIONING AND WAS REMOVED FROM THE CATHETER AND NOT USED DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18517008 ↗
• InjuryDec 22, 2023Expulsion; Expulsion

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT COIL WAS PROTRUDED OUT OF THE ANEURYSM AS THE SUBJECT DEVICE WAS TOO LARGE TO SIT UNIFORMLY ACROSS THE NECK. THEREFORE, THE STENT WAS USED BECAUSE OF THE COIL PROTRUSION NEAR THE NECK/PARENT VESSEL. THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. PATIENT JUST COMPLETED 2 MONTH FOLLOW UP WITH MRS (MODIFIED RANQUIN SCALE) AND NIHSS (NATIONAL INSTITUTE OF HEALTH STROKE SCALE) OF 0.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18386397 ↗
• MalfunctionSep 28, 2023Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT COIL GOT FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17840896 ↗
• MalfunctionJun 28, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL COULD NOT BE DETACHED AND WHEN WITHDRAWN, THE SUBJECT COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER. 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 17214986 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT AFTER THE STUDY PROCEDURE WITHIN 48 HOURS, THE PATIENT HAD EXPERIENCED WITH ISCHEMIC STROKE AT BASILAR TIP. THE OUTCOME OF STROKE IS STILL ON GOING. THE PATIENT WAS DISCHARGED 5 DAYS AFTER THE PROCEDURE WITH THE MODIFIED RANKIN SCALE (MRS) OF 1 AND NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 0. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Ischemia Stroke

  MAUDE report 16493334 ↗
• InjuryJan 17, 2023Expulsion; Adverse Event Without Identified Device or Use Problem; Expulsion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING STENT ASSISTED COILING PROCEDURE, PHYSICIAN ATTEMPTED TO PUT SUBJECT COIL AS THE LAST COIL. HE REPOSITIONED THE SUBJECT COIL TWO TIMES, HOWEVER THE COIL WAS UNABLE TO BE ADVANCED OR RETRACT AS THERE WAS A COIL TAIL REMAINING IN THE INTERNAL CAROTID ARTERY (ICA). PHYSICIAN USED A STENT TO PIN THE COIL AGAINST THE VESSEL WALL. HE THEN TRIED TO DETACH THE SUBJECT COIL BUT WAS UNABLE TO DO SO. WHILE HE TRIED REMOVING THE DELIVERY WIRE THE SUBJECT COIL APPEARED TO BE STRETCHED. HE THAN HAD TO SUBSEQUENTLY USE TWO CAROTID STENTS TO PIN THE STRETCHED COIL UP AGAINST THE VESSEL WALL. THE ADDITIONAL STENTING RESULTED IN AN HOUR PROCEDURAL DELAY. 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 16186378 ↗
• InjuryDec 12, 2022Expulsion; Expulsion

  IT WAS REPORTED THAT DURING ANEURYSM EMBOLIZATION PROCEDURE, THE SUBJECT COIL WAS PROTRUDING FROM THE TARGET LESION. THE PHYSICIAN USED AN ADDITIONAL STENT TO TACK UP 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 15957761 ↗
• MalfunctionDec 9, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL PREMATURELY DETACHED WITHIN THE MICROCATHETER WHEN INSERTED INTO IT. THE SUBJECT COIL WAS REMOVED ALONG WITH THE MICROCATHETER. 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 15951337 ↗
• MalfunctionNov 28, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A PROCEDURE FOR THE EMBOLIZATION OF UNRUPTURED CEREBRAL ANEURYSM IN THE INTERNAL CAROTID ARTERY. THE COIL (SUBJECT DEVICE) COULD NOT BE FRAMED AS INTENDED (THERE WAS DIFFICULTY ENGAGING THE TARGET VESSEL). DURING AN ATTEMPT TO REMOVE THE COIL (SUBJECT DEVICE) FROM THE PATIENT'S ANATOMY, IT WAS PREMATURELY DETACHED WITHIN 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 15873986 ↗
• MalfunctionJan 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE COIL (SUBJECT DEVICE) ENCOUNTERED RESISTANCE IN THE MIDDLE OF THE CATHETER. THE COIL WAS BROKE WITHIN 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 13179860 ↗
• MalfunctionOct 21, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING IIA COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN GUIDED THE MICROCATHETER INTO THE LESION AND DEPLOYED THE SUBJECT COIL INTO THE PATIENT BLOOD VESSEL. AFTER REPEATED FRAMING WORK, THE SUBJECT COIL WAS PREMATURELY DEPLOYED INSIDE THE LUMEN OF THE MICROCATHETER. THE PREMATURELY DEPLOYED SUBJECT COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. THERE WAS NO REMAINING COIL INSIDE THE PATIENT ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY ANOTHER METHOD OTHER THAN THE COIL EMBOLIZATION WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12677353 ↗
• MalfunctionAug 23, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT A COIL EMBOLIZATION PROCEDURE WAS PERFORMED IN PEDIATRICS FOR MAPCA (MAJOR AORTOPULMONARY COLLATERAL ARTERIES) CASE. DURING THE PROCEDURE DURING EMBOLIZATION OF TARGETED ARTERY WHILE ADVANCEMENT OF THE SUBJECT COIL FROM TIP OF THE MICROCATHETER TO THE TARGETED SITE, SUBJECT COIL DETACHED PREMATURELY IN THE NON-STRYKER MICROCATHETER AND WITH A SUBJECT COIL DELIVERY WIRE THE PHYSICIAN PUSHED THE PREMATURELY DETACHED SUBJECT COIL TO THE TARGETED SITE. 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 12355791 ↗
• InjuryMar 27, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE OF COIL EMBOLIZATION FOR DURAL AVF(ARTERIOVENOUS FISTULAE), AFTER ADVANCEMENT OF THE SUBJECT COIL INTO THE MICROCATHETER, IT WAS TAKEN IN AND OUT SEVERAL TIMES. THE SUBJECT COIL CUT OFF INSIDE THE MICROCATHETER AND THE OPERATOR WAS ABLE TO REMOVE ALL PART OF THE BROKEN/CUT OFF COIL FROM THE PATIENT ANATOMY BY A SNARE DEVICE. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11579823 ↗
• MalfunctionMar 6, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE COIL (SUBJECT DEVICE) WAS STUCK WITHIN THE MICROCATHETER. UPON REMOVAL THE SUBJECT COIL WAS PREMATURELY DETACHED AND WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9796367 ↗
• MalfunctionFeb 26, 2020Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL (SUBJECT DEVICE) DELIVERY WIRE WAS BROKEN AND FRACTURED AND THE COIL 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 Known Impact Or Consequence To Patient

  MAUDE report 9758611 ↗
• InjuryJul 17, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED DURING COIL EMBOLIZATION PROCEDURE, THE MAIN COIL WAS DELIVERED INTO THE OPHTHALMIC ANEURYSM, HOWEVER THE DETACHED COIL WAS PROTRUDING OUT OF THE ANEURYSM INTO THE PARENT VESSEL. THE PHYSICIAN ELECTED TO USE A FLOW DIVERTER TO PREVENT ANEURYSMAL FILLING AND PUSH THE COIL TAIL TO VESSEL WALLS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8799883 ↗
• MalfunctionMay 23, 2018Break; Break

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN CRIMPED THE TIP OF THE SHEATH STRONGLY INTO THE HUB OF THE MICROCATHETER CAUSING THE SUBJECT COIL DISTAL TIP TO BREAK. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7539149 ↗
• MalfunctionJul 6, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL ENCOUNTERED RESISTANCE IN THE MICROCATHETER AND WAS PREMATURELY DETACHED UPON WITHDRAWAL. THE COIL AND MICROCATHETER WERE RETRIEVED AS ONE UNIT WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5773109 ↗
• MalfunctionJul 6, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL (SUBJECT DEVICE) WAS REPOSITIONED SEVERAL TIMES AND PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE COIL AND MICROCATHETER WERE RETRIEVED TOGETHER AS ONE UNIT WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5773068 ↗