TARGET XL M0036128300Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 07613327004649), received between Jun 20, 2016 and Sep 5, 2025 — classified as 1 death, 9 injuries, 23 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2025Fracture; Premature Separation; Fracture; Premature Separation

  IT WAS REPORTED THAT DURING RUPTURED ANEURYSM PROCEDURE; THE OPERATOR USED THE SUBJECT COIL AS THE FIRST COIL. HOWEVER, AFTER ABOUT 1/4 OF THE COIL WENT OUT OF THE MICROCATHETER, THE COIL DETACHED PREMATURELY. THE DETACHED COIL OCCLUDED THE INTERNAL CAROTID ARTERY (ICA) AND MIDDLE CEREBRAL ARTERY (MCA). THE OPERATOR TRIED TO USE MULTIPLE TOOLS SUCH AS 6 STENT RETRIEVERS, 2 SNARES AND A FILTER WIRE TO EXTRACT THE SUBJECT COIL BUT UNSUCCESSFULLY AS ONLY FRAGMENTS OF THE SUBJECT COIL WERE COMING OUT. THE OPERATOR DECIDED TO STENT THE REMAINING PART OF THE VESSEL TO COVER THE LOOSE FLOATING COIL. THIS RESULTED IN 8 HOURS SURGICAL DELAY. THE PATIENT EXPERIENCED SIGNIFICANT VASCULAR OCCLUSION, DEFICIT AND DIED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22984029 ↗
• MalfunctionJul 2, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE BASILAR TIP ANEURYSM PROCEDURE, THE SUBJECT COIL DEPLOYED PREMATURELY INSIDE THE MICROCATHETER. 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 22386709 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT HAD RIGHT OCCIPITAL ISCHEMIC STROKE AND LOSS OF VISION ON THE LEFT EYE POST PROCEDURE ON (B)(6) 2024 AS THE INITIAL PROCEDURE WAS SUCCESSFULLY COMPLETED ON (B)(6) 2024. THE PATIENT WAS HOSPITALIZED AND WAS TREATED WITH THE MEDICATION (ASPIRIN) AS NO MEDICAL INTERVENTION WAS REQUIRED. THE OUTCOME OF THIS ADVERSE EVENT WAS RESOLVED, WITH SEQUELAE. PER THE MEDICAL RECORD, THE PATIENT HAS RIGHT-SIDED HEMIANOPIA BUT OTHERWISE NO OTHER DEFICITS ARE KNOWN. FROM A MEDICAL OPINION PERSPECTIVE, THE CAUSE OF THE STROKE POST PROCEDURE WAS UNKNOWN ETIOLOGY-POSSIBLY ACUTE COCAINE VASCULOPATHY, CLOT DISLODGEMENT FROM ANEURYSM INTO THE PCA, IMPEDED FLOW IN THE VESSELS SURROUNDING THE TARGET ANEURYSM RELATED TO THE INDEX TREATMENT. IN PHYSICIAN¿S OPINION, THE SUBJECT DEVICE PERFORMED AS INTENDED AND THERE WERE NO ALLEGATIONS AGAINST IT. UPDATE: BASED ON THE ADDITIONAL INFORMATION RECEIVED FROM SAFETY ON 17-DEC-2024 THAT THE SITE ALSO UPDATED THE RELATEDNESS SECTION AND ACCORDING TO THIS UPDATE, THIS EVENT WAS NOT RELATED TO SUBJECT DEVICE. THIS IS CONSISTENT WITH THE RESULTS OF CEC ADJUDICATIONS. IN PHYSICIAN¿S OPINION, THE SUBJECT COIL DEVICE PERFORMED AS INTENDED

  Patient problems: Loss of Vision; No Clinical Signs, Symptoms or Conditions; Stroke/CVA

  MAUDE report 20659145 ↗
• MalfunctionJul 10, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING P-AVM TREATMENT, THE SUBJECT COIL WAS SELECTED AFTER THREE COILS HAD ALREADY BEEN IMPLANTED. THE SUBJECT COIL DETACHED PREMATURELY WHEN IT WAS BEING RETRACTED INTO THE INTRODUCER SHEATH TO REPOSITION THE MICROCATHETER TIP DURING PLACEMENT. THE MICROCATHETER WAS WITHDRAWN FROM THE BODY, THE PREMATURELY DETACHED SUBJECT COIL WAS PUSHED OUT, AND THE SAME MICROCATHETER WAS USED TO ACCESS THE TARGET SITE AGAIN TO CONTINUE EMBOLIZATION. 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 19714047 ↗
• InjuryApr 2, 2024Stretched; Stretched

  IT WAS REPORTED THAT DURING LEFT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM EMBOLIZATION CASE, SUBJECT COIL GOT STRETCHED WHILE REPOSITIONING IT NEAR TARGET LESION. THIS STRETCHED SUBJECT COIL WAS RETRIEVED FROM PATIENT¿S BODY USING A SNARE DEVICE AS MEDICAL INTERVENTION. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19018126 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST 'ANTERIOR COMMUNICATING ARTERY COMPLEX (ACOM) PROCEDURE, THE INFARCT AREA WAS SEEN ON THE IMAGING (COMPUTED TOMOGRAPHY) AS NO TREATMENT WAS PROVIDED TO THE PATIENT AND THE EVENT WAS RESOLVED WITHOUT SEQUELAE TO THE PATIENT.

  Patient problems: Stroke/CVA

  MAUDE report 18823125 ↗
• MalfunctionFeb 26, 2024Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE COIL (SUBJECT DEVICE) WAS BROKEN/FRACTURED DURING USE. 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 18785020 ↗
• MalfunctionOct 5, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL (SUBJECT DEVICE) DETACHED PREMATURELY 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 17881926 ↗
• MalfunctionAug 1, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE INTERNAL CAROTID POSTERIOR COMMUNICATING (ICPC) RUPTURED ANEURYSM, THE OPERATOR ENCOUNTERED RESISTANCE WHILE ADVANCING THE SUBJECT COIL WITHIN THE MICROCATHETER SHAFT. WHEN THE SUBJECT COIL WAS RETRIEVED, IT WAS DISCOVERED THAT THE SUBJECT COIL PREMATURELY DETACHED. 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 17434448 ↗
• InjuryJun 19, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, REPOSITIONING OF THE COIL (SUBJECT DEVICE), WAS ATTEMPTED. FOLLOWING THIS, THE COIL (SUBJECT DEVICE) DETACHED PREMATURELY. A SNARE DEVICE WAS REQUIRED TO REMOVE THE COIL. 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 17154436 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME FOR FOLLOW UP AND THE ANEURYSM RUPTURE (BECAME UNRAVELED), THROMBOSED WERE OBSERVED ON IMAGING CTA (COMPUTERIZED TOMOGRAPHY ANGIOGRAPHY) HEAD AND NECK. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Ruptured Aneurysm; Thrombosis/Thrombus

  MAUDE report 16912135 ↗
• MalfunctionFeb 1, 2023Premature Separation; Premature Separation

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE COIL PREMATURELY DETACHED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280373 ↗
• MalfunctionJun 6, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE SUBJECT COIL WITHIN THE MICROCATHETER. THE DELIVERY WIRE OF THE SUBJECT COIL SEEMED TO BE KINKED, SO IT WAS RETRIEVED AND THE SUBJECT COIL WAS FOUND DETACHED PREMATURELY INSIDE THE MICROCATHETER. THE SUBJECT COIL WAS REMOVED ALONG WITH THE MICROCATHETER. THE MICROCATHETER WAS REINSERTED AND THE PROCEDURE WAS COMPLETELY SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14600210 ↗
• MalfunctionApr 6, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE FOR A RUPTURED MCA (MIDDLE CEREBRAL ARTERY) ANEURYSM, WHEN THE SUBJECT COIL FAILED TO DETACH AND WAS BEING RETRIEVED, IT GOT PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE DELIVERY WIRE WAS THEN USED TO PUSH THE SUBJECT COIL OUT OF THE MICROCATHETER INTO THE 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 14023304 ↗
• MalfunctionSep 22, 2021Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT COIL PREMATURELY DETACHED/SEPARATED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12511321 ↗
• MalfunctionMay 24, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE COIL (SUBJECT DEVICE) DELIVERY WIRE WAS BROKEN INSIDE THE CATHETER. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11873810 ↗
• MalfunctionMay 17, 2021Fracture; Fracture

  IT WAS INITIALLY REPORTED THAT THE COIL (SUBJECT DEVICE) WAS STRETCHED DURING USE. ANALYSIS OF THE RETURNED MAIN COIL (SUBJECT DEVICE) WAS FOUND TO BE BROKEN DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11833111 ↗
• InjuryMar 18, 2021Migration; Migration

  IT WAS REPORTED THAT DURING A CEREBRAL ANEURYSM COILING EMBOLIZATION PROCEDURE, THE SUBJECT COIL WAS UNRAVELED MIDWAY THROUGH DEPLOYMENT IN THE ANEURYSM. THE NEURO-INTERVENTIONALIST DID UNSUCCESSFUL ATTEMPT TO REMOVE THE DEFECTIVE UNRAVELED SUBJECT COIL USING MULTIPLE DEVICES WITHOUT DISRUPTING THE PARTIALLY DEPLOYED COIL WITHIN THE ANEURYSM. THE STENT WAS DEPLOYED TO SECURE THE TAIL OF THE SUBJECT COIL PROTRUDING OUT OF ANEURYSM AGAINST THE WALL OF THE NATIVE VESSEL. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516529 ↗
• MalfunctionFeb 4, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, A COIL WAS NOTED TO BE BROKEN OFF WHEN ATTEMPTING TO REMOVE THE DEVICE OUT OF THE ANEURYSM INSIDE THE MICROCATHETER. THE COIL AND CATHETER WAS REMOVED SUCCESSFULLY AND REPLACED WITH THE SUBJECT COIL AND NEW MICROCATHETER TO CONTINUE PROCEDURE. A SIMILAR EVENT IN WHICH SUBJECT COIL HAD BROKEN OFF WITHIN MICROCATHETER OCCURRED AFTER. SUBJECT COIL AND MICROCATHETER WERE REMOVED AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO NOTED CLINICAL CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11283310 ↗
• MalfunctionSep 18, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT WHEN TRYING TO INSERT THE SUBJECT COIL INTO THE MICROCATHETER, THE SUBJECT COIL STRETCHED AND DETACHED INSIDE THE PROXIMAL PART OF THE MICROCATHETER. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10552275 ↗
• MalfunctionMar 20, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING EMBOLIZATION OF RENAL ANEURYSM, WHEN COIL (SUBJECT DEVICE) WAS ATTEMTED TO INSERT THERE WAS RESISTANCE INSIDE THE MICROCATHETER AND COIL WAS RETRACTED WHICH FOUND OUT TO BE PREMATURELY DETACHED AND BENT OF THE DELIVERY WIRE WAS ALSO NOTICED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY PLACING THE DETACHED COIL USING MICRO GUIDE WIRE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9862958 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED WHILE INSERTING THE SUBJECT COIL INTO THE MICRO CATHETER, AND WHEN THE SUBJECT COIL WAS ATTEMPTED TO RETRACT, THE COIL WAS STRETCHED AND WAS UNABLE TO RETRACT, SO THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE SUBJECT COIL. THE PRODUCT WAS EXCHANGED AND 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 9709203 ↗
• MalfunctionJan 27, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE UPON INSERTING THE COIL (SUBJECT DEVICE) INTO THE MICROCATHETER. THE PHYSICIAN PROCEEDED TO REMOVE THE COIL AND MICROCATHETER AND HAD IDENTIFIED THAT THE SUBJECT COIL HAD DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN PROCEEDED TO REMOVE AND EXCHANGE BOTH THE SUBJECT DEVICE AND MICROCATHETER. THE PROCEDURE CONTINUED AND COMPLETED WITHOUT CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9635306 ↗
• InjuryJan 7, 2020Expulsion; Expulsion

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT COIL WAS STRETCHED DURING DETACHMENT AND THE DETACHED COIL PROTRUDED OUT OF THE ANEURYSM. THE STENT WAS PLACED TO TACK THE PROXIMAL END OF THE COIL DOWN AND COMPLETED THE PROCEDURE. THE FOLLOWING DAY (AFTER PROCEDURE) PATIENT FOUND TO HAVE SUDDEN ONSET OF LEFT SIDED WEAKNESS AND RIGHT GAZE PREFERENCE. STROKE ALERT CALLED AND CONFIRMED ACUTE RIGHT FRONTAL INFARCT. HEPARIN DRIP STARTED AND THEN DISCONTINUED ABOUT AN HOUR LATER. PATIENT WAS MONITORED AND IMPROVEMENT RECOGNIZED WITH MILD LEFT SIDED WEAKNESS. THE PATIENT WAS DISCHARGED TO REHAB ON (B)(6) 2019. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Neurological Deficit/Dysfunction; Stroke/CVA

  MAUDE report 9561957 ↗
• MalfunctionJul 29, 2019Break; Break

  DURING COIL EMBOLIZATION OF COMMON HEPATIC ARTERY (CHA) ANEURYSM, PHYSICIAN EXPERIENCED DIFFICULTY INSERTING COIL INTO MICROCATHETER HUB. PHYSICIAN RE-SHEATHED COIL AND ATTEMPTED TO INSERT COIL AGAIN BUT FELT RESISTANCE AND COIL BROKE OFF HALFWAY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8837926 ↗