TARGET XL M0036127200Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07613327004632), received between Nov 18, 2016 and Mar 25, 2026 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (12 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Fracture; Premature Separation

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SUBJECT MAIN COIL WAS FOUND WITHIN THE MICROCATHETER DETACHED FROM THE DELIVERY WIRE AND THE SUBJECT MAIN COIL WAS SEEN TO BE FRACTURED. 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 24684311 ↗
• MalfunctionApr 30, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE DISTAL PART SUBJECT MAIN COIL GOT STRETCHED AND THE SUBJECT COIL WAS PREMATURELY DETACHED IN THE MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED; THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE SUBJECT COIL WAS RETURNED FOR ANALYSIS. THE COIL WAS EXAMINED, AND IT WAS DISCOVERED THAT THE REPORTED EVENT OF THE SUBJECT MAIN COIL BEING PREMATURELY DETACHED DURING THE PROCEDURE WAS NOT CONFIRMED. THE RETURNED MAIN COIL WAS FOUND TO BE STRETCHED, KINKED/BENT, SUTURE DAMAGED AND COIL DELIVERY WIRE WAS KINKED/BENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938340 ↗
• MalfunctionMar 5, 2025Entrapment of Device; Stretched; Premature Separation; Entrapment of Device; Stretched; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE THERE WAS RESISTANCE WHILE ADVANCING THE SUBJECT COIL INSIDE THE CATHETER. WHEN ATTEMPTING TO WITHDRAW THE DEVICE FROM THE CATHETER, IT BECAME STRETCHED AND DETACHED. THE CATHETER AND COIL WERE REMOVED FROM THE PATIENT. A FIVE-MINUTE DELAY IN SURGERY WAS REPORTED. THE SUBJECT COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON 06-MAR-2025 CLARIFIED THAT THE SUBJECT COIL WAS DETACHED WITHIN THE MICROCATHETER OUTSIDE THE PATIENT'S BODY, AND NOT DURING THE PROCEDURE AS REPORTED. THERE WAS NO INFORMATION TO REASONABLY SUGGEST THAT THIS TYPE OF MALFUNCTION WOULD LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO REOCCUR. BASED ON THE INFORMATION, THIS EVENT NO LONGER MEETS REPORTING CRITERIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21521767 ↗
• MalfunctionSep 11, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN UNRUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY, A STENT WAS IMPLANTED USING THE TRANS CELL TECHNIQUE AND A MICROCATHETER WAS PLACED IN THE ANEURYSM. EMBOLIZATION WAS STARTED WITH THE SUBJECT COIL AS THE FRAMING COIL. FOR THE REPOSITIONING OF THE SUBJECT COIL TO ENGAGE WITH THE ANEURYSM, THE DELIVERY WIRE WAS RETRACTED TO PULL THE SUBJECT COIL BACK TO THE MICROCATHETER. WHILE ABOUT TWO LOOPS OF THE SUBJECT COIL WERE OUT OF THE MICROCATHETER, IT WAS FOUND THAT THE SUBJECT COIL WAS NOT SEEN UNDER THE FLUOROSCOPY. WHEN THE DELIVERY WIRE OF THE SUBJECT COIL WAS PULLED CAREFULLY, IT WAS FOUND THAT THE SUBJECT COIL WAS PREMATURELY DETACHED. THE ENTIRE MICROCATHETER WAS REMOVED FROM THE BODY, AND THE PREMATURELY DETACHED SUBJECT COIL WAS REMOVED OUT OF 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 20191726 ↗
• MalfunctionMar 7, 2024Expulsion; Expulsion

  IT WAS REPORTED THAT THE PATIENT WHO UNDERWENT A COIL EMBOLIZATION FOR THE TREATMENT OF AN ANEURYSM LOCATED IN THE BASILAR APEX. THE TARGET ANEURYSM WAS UNRUPTURED AND SACCULAR, LOCATED IN THE BASILAR APEX WITH DOME HEIGHT OF 7.1 MM, DOME WIDTH OF 10.6 MM, DOME DEPTH OF 9.1 MM, AND NECK WIDTH OF 5.6 MM. THE DOME TO NECK RATIO WAS 1.89. THE PARENT VESSEL DIAMETER WAS 4.6 MM PROXIMAL TO THE ANEURYSM NECK AND 4.6 MM DISTAL TO THE ANEURYSM NECK. THE INDEX PROCEDURE WAS PERFORMED, AND THE SUBJECT COIL WAS SUCCESSFULLY DEPLOYED. THE SUBJECT COIL HERNIATION WAS NOTICED AT 6-MONTH VISIT ANGIOGRAM AND THE MEDICATION WAS ADMINISTERED TO THE PATIENT. THE SUBJECT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18858150 ↗
• MalfunctionApr 10, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF COMMON HEPATIC ARTERY PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN MOVING THE SUBJECT COIL IN AND OUT OF THE CATHETER AND PREMATURE DETACHMENT OCCURRED DURING MANIPULATION. THUS, THE COIL AND THE CATHETER WAS REMOVED TOGETHER. THE PROXIMAL PART OF THE SUBJECT COIL WAS FOUND STRETCHED. 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 16710488 ↗
• MalfunctionJun 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION WITH A DOUBLE CATHETER, THE COIL (SUBJECT DEVICE ) WAS IMPLANTED AS THE FIRST COIL AND OTHER THREE NON-STRYKER COILS WERE IMPLANTED INSIDE THE COIL (SUBJECT DEVICE). DURING ATTEMPT TO DETACH THE COIL (SUBJECT DEVICE) WITH INZONE, THE COIL DELIVERY WIRE (SUBJECT DEVICE) WAS BROKEN AT THE PROXIMAL CONTACT. THE COIL (SUBJECT DEVICE) COULD NOT BE REMOVED BECAUSE OTHER THREE COILS WERE ALREADY IMPLANTED, SO THE PHYSICIAN TRIED TO DETACH THE COIL (SUBJECT DEVICE) WITH INZONE BUT IT COULDN'T DETACH. THE PHYSICIAN EXPOSED AN ANODE INSIDE THE DELIVERY WIRE AND THE COIL (SUBJECT DEVICE) WAS FINALLY DETACHED USING BARRICADE COIL DETACHMENT SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14744422 ↗
• MalfunctionMay 23, 2022Premature Separation; Premature Separation

  IT WAS REPORTED DURING THAT DURING COILS EMBOLIZATION, THE SUBJECT COIL WAS INSERTED AND DURING PLACING, IT WAS DETACHED PREMATURELY. AS A RESULT, THE PHYSICIAN USED THE NEW COILS AND MICROCATHETER TO COMPLETE THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14471006 ↗
• InjuryMar 24, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF AN ANEURYSM AT THE BIFURCATION OF THE OPHTHALMIC ARTERY, SL-10 AND HEADWAY 17 MICROCATHETERS WERE PLACED IN THE ANEURYSM, AND ATLAS STENT WAS PLACED FOR COIL EMBOLIZATION USING THE JAIL METHOD. WHEN THE COIL (SUBJECT DEVICE) WAS INSERTED AS THE FIRST COIL, THE SL-10 MICROCATHETER WAS KICKED BACK OUT OF THE ANEURYSM. WHILE RETRACTING THE COIL (SUBJECT DEVICE), THERE WAS A FEELING OF BEING STUCK IN THE ATLAS DUE TO STRONG RESISTANCE. WHEN THE COIL (SUBJECT DEVICE) WAS SLOWLY RETRACTED, THE DETACHMENT PART WAS DETACHED. THUS, THE MICROCATHETER WAS RETRACTED SLOWLY, THE COIL (SUBJECT DEVICE) HAS ALSO COME ALONG WITH THE MICROCATHETER, THEN IT HAPPENED TO DRAG AND MIGRATE THE ATLAS STENT. A GOOSENECK USED AS A MEDICAL INTERVENTION TO RETRIEVE THE COIL (SUBJECT DEVICE). AT THAT TIME, BECAUSE THE COIL (SUBJECT DEVICE) WAS ENTANGLED IN THE STRUT OF THE ATLAS, THE ATLAS WAS RETRIEVED TOGETHER WITH THE COIL (SUBJECT DEVICE), AND THE COIL (SUBJECT DEVICE) WAS REMOVED IN THE GUIDE CATHETER (OPTIMO 9FR). THERE WAS SOME SPASM, WHICH MAY HAVE BEEN CAUSED BY THE STIMULATION OF STENT REMOVAL, BUT IT RESOLVED WITH TIME. A CT SCAN WAS DONE IMMEDIATELY

  Patient problems: Vasoconstriction

  MAUDE report 13879095 ↗
• InjuryAug 23, 2021Fracture; Expulsion; Fracture; Expulsion

  IT WAS REPORTED THAT THE SUBJECT COIL WAS USED DURING THE COIL EMBOLIZATION PROCEDURE FOR AN ANEURYSM LOCATED AT THE ANTERIOR COMMUNICATING ARTERY (ACOM). AFTER THE FIRST PLACEMENT, A SLING LYING SUB-OPTIMALLY AT THE NECK WAS NOTED DUE TO THE STRETCHED SUBJECT COIL, AND THE COIL WAS PULLED WITHOUT A PROBLEM WITH 50-70% RETURN. WHEN REINSERTING THE COIL, A NEW SLING WAS ALSO NOTED, AND THE COIL WAS RETRACTED WITHOUT FEELING OF RESISTANCE. AT ABOUT 50% A CRACK WAS FELT AND THE COIL CAN NO LONGER BE CONTROLLED. THE PHYSICIAN TEN RETRACTED THE MICROCATHETER WITH PART OF THE COIL. A COMPLETELY DISTAL NODULE WAS NOTED ON THE COIL AND A SNARE DEVICE WAS USED TO CAPTURE AND REMOVE THE COIL. IMAGING SHOWED THROMBI AROUND THE NECK WITH THE CLOSURE OF ONE ANTERIOR BRANCH DUE TO THE PROLONGED STAY OF THE COIL AT THIS POSITION. INTEGRILIN WAS GIVEN TO THE PATIENT, AND THE THROMBUS SLOWLY DISSOLVES AFTER 20 MINUTES. TWO SMALL DISCRETE INFARCTS IN THE ANTERIOR SUPPLY AREA WERE NOTED. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 20-SEP-2021 INDICATING THAT THE PATIENT LUCKILY HAD NO SEQUELAE.

  Patient problems: Obstruction/Occlusion; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 12356489 ↗
• MalfunctionJul 14, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, A COIL (SUBJECT DEVICE) WAS INSERTED INSIDE THE PATIENT¿S ANATOMY IN COMBINATION WITH A MICROCATHETER. THE SUBJECT COIL ENCOUNTERED RESISTANCE INSIDE THE MICROCATHETER DURING ADVANCEMENT. WHEN THE PHYSICIAN CONTINUED TO DELIVER THE SUBJECT COIL, IT PREMATURELY DETACHED WITHOUT DETACHMENT ATTEMPT INSIDE THE MICROCATHETER. THE SUBJECT COIL WAS REMAINED INSIDE THE MICROCATHETER AND WAS REMOVED ALONG WITH THE REMOVAL OF THE MICROCATHETER FROM THE PATIENT¿S ANATOMY. 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 12167229 ↗
• MalfunctionApr 2, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE EMBOLIZATION THE SUBJECT COIL WAS INSERTED INTO THE MICRO CATHETER. WHILE ADVANCING THE SUBJECT COIL AT THE MIDDLE OF THE MICRO CATHETER RESISTANCE WAS FELT. WHEN THE PHYSICIAN PULLED THE DELIVERY WIRE OF THE SUBJECT COIL IT PREMATURELY DETACHED INSIDE THE MICRO CATHETER. 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 11610317 ↗
• MalfunctionDec 28, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL ENCOUNTERED RESISTANCE WHEN ADVANCING THE COIL OUT OF THE INTRODUCER SHEATH AND THE COIL WAS PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE COIL WAS REMOVED WITH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. NO PATIENT CONSEQUENCES WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11074677 ↗
• MalfunctionNov 25, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) DETACHED PREMATURELY DURING THE PROCEDURE. THE DETACHED SUBJECT COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S ANATOMY. 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 10899456 ↗
• InjuryOct 23, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING EMBOLIZATION PROCEDURE FOR A GASTRIC DUODENAL ARTERY ANEURYSM, THE PHYSICIAN FELT COIL (SUBJECT DEVICE) RESISTANCE INSIDE THE MICROCATHETER AND WHILE ATTEMPTING TO RETRACT THE COIL, IT PREMATURELY DETACHED AND REMAINED INSIDE THE PATIENT'S VESSEL UNDER THE ANEURYSM. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ADDITIONAL COIL WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9227546 ↗
• InjuryJul 22, 2019Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A STENT ASSISTED COILING OF ANEURYSM AT THE MIDDLE CEREBRAL ARTERY(MCA) BRANCH, THE COIL(SUBJECT DEVICE) WAS REPOSITIONED AND WRAPPED AROUND THE STENT. THE PATIENT RETURNED WITH AN ACUTE OCCLUSION OF THE M2 BRANCH DUE TO IN-STENT THROMBOSIS. THE PHYSICIAN ADMINISTERED TPA (TISSUE PLASMINOGEN ACTIVATOR) AND OTHER MEDICATION TO BREAKUP THE CLOT AND RESTORE BLOOD FLOW, NO OTHER MEDICAL INTERVENTIONS WERE PERFORMED. IT WAS REPORTED THE PATIENT IS STABLE HOWEVER, PATIENT WAS REPORTED TO HAVE CONTINUED STOKE SYMPTOMS AND APHASIA AS A RESULT OF THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Dysphasia; Stroke/CVA; Thrombosis

  MAUDE report 8813769 ↗
• MalfunctionJun 13, 2018Break; Break

  IT WAS REPORTED THAT THERE WAS A SLIGHT RESISTANCE DURING MICROCATHETER INSERTION OF THE MAIN COIL (SUBJECT DEVICE) AND THE COIL DELIVERY WIRE BROKE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 7599166 ↗
• MalfunctionNov 18, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT WHEN THE COIL WAS ADVANCED IN THE MICROCATHETER, THE COIL GOT STUCK AND WAS DETACHED PREMATURELY. 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 6112865 ↗