TARGET XL M0036129300Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04546540711618), received between Mar 30, 2017 and Aug 4, 2025 — classified as 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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.

• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT COIL WAS SUCCESSFULLY IMPLANTED INTO THE TARGET ANEURYSM ON (B)(6) 2024. POST-PROCEDURE, IMAGING DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) REVEALED AN OCCLUSION STATUS POST-IMPLANT ASSESSMENT ¿ RAYMOND CLASS OF 1. DURING PATIENT FOLLOW UP VISITS AT 3 MONTHS, MRI (MAGNETIC RESONANCE IMAGING) TEST WAS PERFORMED ON (B)(6) 2025, AS SHOWED OCCLUSION STATUS RAYMOND ROY SCORE OF 3A. 12 MONTHS IMAGING DSA PERFORMED ON (B)(6) 2025, OCCLUSION STATUS POST-IMPLANT ASSESSMENT ¿ RAYMOND CLASS OF 3B AND MRS (MODIFIED RANKIN SCALE) WAS 0. PER PHYSICIAN¿S OPINION, THE REPORTED EVENT WAS DUE TO COIL COMPACTION AS A NEW EMBOLIZATION PROCEDURE WILL BE SCHEDULED TO TREAT AN INCREASE IN OCCLUSION POST IMPLANT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Aneurysm

  MAUDE report 22701240 ↗
• InjuryJun 8, 2024Fracture; Migration; Premature Separation; Fracture; Migration; Premature Separation

  IT WAS REPORTED THAT DURING THE BASILAR TIP ANEURYSM PROCEDURE, THE PHYSICIAN REPORTED THAT THEY WANTED TO REPLACE THE SIZE OF THE SUBJECT COIL AS THEY FELT IT WAS TOO BIG. THE PHYSICIAN HAD TO REPOSITION THE SUBJECT COIL SEVERAL TIMES. THE SUBJECT COIL STRETCHED UPON WITHDRAWAL OF THE MICROCATHETER AND THE SUBJECT COIL FRACTURED AND DETACHED PREMATURELY IN THE PATIENT'S VESSEL. THE DISTAL SECTION OF THE SUBJECT COIL REMAINED IN THE DOME OF THE ANEURYSM AND THE REMAINDER OF THE SUBJECT COIL REMAINED IN THE PATIENT'S VESSEL. THE PATIENT SUFFERED FROM A INFARCT CEREBELLUM AS A RESULT OF THE EVENT AND WAS PRESCRIBED ANTIPLATELET MEDICATION (PLETAAL TAB 100MG, NIMOTOP TAB 6X60MM, AND MANITOL 4X150CC). THE PATIENT STATUS IS STABLE WITH A GLASGOW COMMA SCORE (GCS) OF 15.

  Patient problems: Stroke/CVA; Vasoconstriction

  MAUDE report 19493739 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR COMMUNICATING ARTERY COMPLEX (ACOM) PROCEDURE AS IT WAS PERFORMED UNDER GENERAL ANESTHESIA VIA RIGHT RADIAL ACCESS. THE THROMBUS FORMATION WAS OBSERVED AND IT WAS RESOLVED WITH IV INTEGRILLIN. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18823124 ↗
• MalfunctionFeb 6, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE DISTAL CERVICAL SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY DISSECTING PSEUDOANEURYSM EMBOLIZATION PROCEDURE THE SUBJECT COIL DEPLOYED WITHIN THE MICROCATHETER. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18655474 ↗
• InjuryFeb 2, 2024Fracture; Premature Activation; Fracture; Premature Activation

  IT WAS REPORTED THAT DURING MIDDLE CEREBRAL ARTERY RUPTURED ANEURYSM COILING PROCEDURE, THE PHYSICIAN NOTICED THAT THE SUBJECT COIL LOOP WAS OBSTRUCTING FLOW INTO THE VESSEL PRIOR TO THE DEPLOYMENT. PHYSICIAN DECIDED TO PULL THE SUBJECT COIL OUT AND RESHEATH IT. WHILE WITHDRAWING, THE SUBJECT COIL STRETCHED, BROKE AND DETACHED PREMATURELY WITHIN THE MICROCATHETER. THE PHYSICIAN PULLED THE MICROCATHETER AND INTERMEDIATE CATHETER OUT. HALF OF THE SUBJECT COIL WAS IN THE ANEURYSM THE OTHER HALF WAS OUTSIDE THE ANEURYSM FROM MIDDLE CEREBRAL ARTERY TO CERVICAL INTERNAL CAROTID ARTERY. PHYSICIAN ATTEMPTED TO RETRIEVE THE BROKEN COIL USING A STENT RETRIEVER AND A MICRO SNARE KIT, HOWEVER, FAILED TO DO SO. PHYSICIAN DECIDED TO LEAVE THE BROKEN SUBJECT COIL INSIDE PATIENT AS IT WAS NOT FLOW OBSTRUCTING AT THE END OF THE PROCEDURE. DURING THE RETRIEVAL PROCESS SOME PIECES OF THE BROKEN COIL WERE PULLED OUT OF THE CATHETERS. ADDITIONAL MEDICATION WAS GIVEN TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18633977 ↗
• MalfunctionJan 16, 2024

  STRYKER NEURO COIL DEPLOYED IN CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18516959 ↗
• MalfunctionOct 25, 2023Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT COIL WAS BROKEN/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 18000714 ↗
• MalfunctionDec 16, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) BROKE AND GOT STUCK IN Y CONNECTOR WHILE DEPLOYING THROUGH CATHETER IN 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 15999949 ↗
• MalfunctionFeb 26, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT ENDOVASCULAR COIL EMBOLIZATION PROCEDURE WAS PERFORMED ON BASILAR ARTERY TOP ANEURYSM IN A PATIENT WITH SUB ARACHNOID HEMORRHAGE. AFTER PLACEMENT OF THE SUBJECT COIL INTO THE ANEURYSM WHERE PREVIOUSLY EMBOLIZE COIL MASS WAS PRESENT, EVEN AFTER REPEATED DEPLOYMENT ATTEMPT WITH THE DETACHMENT SYSTEM, COIL WAS UNABLE TO DETACH. SO THE PHYSICIAN WITHDREW IT FROM PATIENT VASCULATURE. WHILE READVANCEMENT ATTEMPT INSIDE THE MICROCATHETER LUMEN, THE SUBJECT COIL GOT PREMATURELY DETACHED. THE PHYSICIAN REMOVED THE MICROCATHETER WITH DETACHED COIL OUTSIDE THE PATIENT VASCULATURE AND EXTERNALLY PHYSICIAN REMOVED DETACHED COIL OUTSIDE THE MICROCATHETER BY PUSHING THE SUBJECT COIL WITH SALINE SOLUTION. 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 13611477 ↗
• MalfunctionFeb 22, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE THE COIL (SUBJECT DEVICE) ENCOUNTERED RESISTANCE WHILE WAS ADVANCING WITHIN THE MICROCATHETER. WHEN THE COIL (SUBJECT DEVICE) WAS RETRIEVED IT PREMATURELY DETACHED IN THE MICROCATHETER. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13579310 ↗
• MalfunctionJan 18, 2022Fracture; Premature Separation; Fracture; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE AT LEFT ICA, THE COIL (SUBJECT DEVICE) DETACHED/SEPARATED AND FRACTURED WHILE ADVANCING INSIDE THE MICROCATHETER. THE SURGEON REPLACED IT WITH A NEW DEVICE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13287507 ↗
• MalfunctionNov 15, 2018Break; Migration; Break; Migration

  IT WAS REPORTED THAT, DURING COIL EMBOLIZATION FOR INTERNAL CAROTID ARTERY-POSTERIOR COMMUNICATING ARTERY (IC-PC) RUPTURED ANEURYSM, AFTER IMPLANTING A FIRST COIL (THE SUBJECT DEVICE) FOR FRAMING THE ANEURYSM, A SECOND COIL WAS INSERTED USING A SECOND MICROCATHETER, BUT STILL ATTACHED TO THE DELIVERY WIRE. THE SECOND COIL BECAME TANGLED WITH THE FIRST COIL AND BOTH WERE REMOVED FROM THE PATIENT'S BODY USING ONE MICROCATHETER. THE PHYSICIAN WAS ABLE TO UNTANGLE THE COILS; HOWEVER, THE COILS WERE BROKEN WHILE OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER COIL. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8076139 ↗
• InjuryNov 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN DECIDED TO REMOVE THE COIL (SUBJECT DEVICE) AFTER IMPLANTATION IN THE ANEURYSM.DURING THE COIL REMOVAL ATTEMPT, THE COIL HAD STRETCHED AND WAS DIFFICULT TO BE REMOVED. IT TOOK TWO AND A HALF HOURS FOR THE PHYSICIAN TO REMOVE THE COIL WITH USE OF A VASCULAR SNARE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8035451 ↗
• MalfunctionAug 1, 2018Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO RETRACT THE COIL INTO THE INTRODUCER SHEATH AND THE COIL DETACHED IN THE SHEATH. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7741548 ↗
• MalfunctionFeb 6, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, BUT THE COIL WASN¿T SITTING IN THE ANEURYSM AS THE PHYSICIAN WANTED AND THE COIL WAS REPOSITIONED MULTIPLE TIMES. PHYSICIAN ALSO MENTIONED THAT SOME RESISTANCE WAS OBSERVED INSIDE THE MICROCATHETER. AS THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL, IT DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN REMOVED THE DETACHED COIL ALONG WITH THE MICROCATHETER WITHOUT ANY CLINICAL CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7244644 ↗
• MalfunctionApr 19, 2017Premature Activation; Premature Activation

  BASED ON THE INVESTIGATION RESULTS, THE MAIN COIL WAS FOUND TO BE DETACHED PREMATURELY INSIDE THE PATIENT. THERE WAS NO CLINICAL IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6505192 ↗
• MalfunctionApr 11, 2017Premature Activation; Premature Activation

  DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS FOUND THAT THE MAIN COIL PREMATURELY DETACHED INSIDE PATIENT. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6482362 ↗
• MalfunctionMar 30, 2017Break; Break

  ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE MAIN COIL WAS BROKEN/ FRACTURED. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6446442 ↗