TARGET XL M0036101240Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04546540711281), received between Jun 7, 2016 and Aug 28, 2025 — classified as 7 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE THE PHYSICIAN FELT A LOT OF FRICTION WHEN HE TRIED TO DEPLOY THE SUBJECT COIL THROUGH THE MICROCATHETER. HE PULLED THE MICROCATHETER OUT UND SAW THE SUBJECT COIL WAS DETACHED MECHANICALLY AT THE DETACHMENT ZONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916502 ↗
• InjuryMay 14, 2025Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE THE SUBJECT COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER WHILE IT WAS PULLED FOR REPOSITIONING. THE DETACHED COIL WAS REMOVED WITH A SNARE DEVICE RESULTING IN A 120 MINUTE SURGICAL DELAY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023600 ↗
• InjuryAug 19, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL DETACHED PREMATURELY INSIDE THE PATIENT ANATOMY BY PUSHING INTO THE MAV IN ANOTHER FRAMING COIL. A NON-STRYKER MICROCATHETER WAS INTRODUCED. A SNARE DEVICE WAS USED AS MEDICAL INTERVENTION TO REMOVE THE SUBJECT COIL FROM PATIENT'S ANATOMY. THERE WAS FIFTEEN MINUTE SURGICAL 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 15259487 ↗
• MalfunctionDec 20, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT COIL EMBOLIZATION FOR PERIPHERAL ANEURYSM WAS PERFORMED. DURING THE PROCEDURE WHILE REPOSITION THE SUBJECT COIL, IT WAS PREMATURELY DETACHED WITHOUT HAVING IT CONNECTED TO THE DETACHMENT DEVICE. THE COIL REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 13048758 ↗
• MalfunctionJun 9, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THE COIL (SUBJECT DEVICE) WAS PRE-DETACHED DURING PROCEDURE AND THE COIL (SUBJECT DEVICE) REMAINED IN PATIENT. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT DUE TO THIS EVENT. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971101 ↗
• InjuryMay 13, 2021Fracture; Fracture

  IT WAS REPORTED THAT FOR TREATING A LARGE UNRUPTURED M2 BIFURCATION ANEURYSM PHYSICIAN USED THE SUBJECT COIL (TARGET COIL) AS THE SIXTH COIL FOR FILLING. DURING THIS ATTEMPT, THE PHYSICIAN FELT RESISTANCE AND DECIDED TO REMOVE THE SUBJECT COIL. RESISTANCE CONTINUED WHILE REMOVING THE SUBJECT COIL FROM THE ANEURYSM AND ITS MID-SECTION STARTED STRETCHING. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO SNARE THE SUBJECT COIL AND WITHDRAW IT FROM THE PATIENT¿S ANATOMY BUT ALL OF THE ATTEMPTS WERE UNSUCCESSFUL. THE SUBJECT COIL GOT FRACTURED DURING THE REMOVAL ATTEMPT DUE TO WHICH THE STRETCHED PART OF THE SUBJECT COIL CAME OFF THE ANEURYSM AND GOT INTO THE M2 SEGMENT DOWN TO THE COMMON CAROTID ARTERY. THE PHYSICIAN DEPLOYED A STENT AS A SNARE DEVICE AND PLACED IN THE M1 SEGMENT TO TACK THE STRETCHED PORTION OF THE SUBJECT COIL. IT WAS REPORTED THAT THE PROCEDURE WAS NOT COMPLETED AND AS PER THE PHYSICIAN, NO ADDITIONAL SURGERY IS PLANNED. NO ADDITIONAL CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816188 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT COIL WAS ATTEMPTED TO PLACE AND RE-PLACING A FEW TIMES AND IT WAS FOUND TO BE STRETCHED. THE SUBJECT COIL WAS REMOVED WITH THE SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER COIL WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10638082 ↗
• MalfunctionAug 10, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE SUBJECT COIL WAS ADVANCING WITHIN THE MICRO CATHETER, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN RETRACTED BOTH THE SUBJECT COIL AND MICRO CATHETER. ON CHECKING THE SUBJECT COIL OUTSIDE THE PATIENT ANATOMY, IT WAS FOUND TO BE STRETCHED. ANALYSIS OF THE DEVICE REVEALED THAT THE SUBJECT MAIL COIL PREMATURELY DETACHED/SEPARATED DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10383769 ↗
• MalfunctionFeb 12, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE COIL (SUBJECT DEVICE) WAS BEING PLACED IN THE ANEURYSM IT DETACHED EARLY. THE COIL WAS REMOVED WITH THE CATHETER. IT WAS EXCHANGED FOR ANOTHER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS GOOD. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9702373 ↗
• InjuryJul 28, 2019Premature Separation; Premature Separation

  DURING THE COIL EMBOLIZATION PROCEDURE FOR A RUPTURED MIDDLE CENTRAL ARTERY (MCA), IT WAS REPORTED THAT THE COIL WAS PREMATURELY DETACHED DURING REPOSITION IN THE ANEURYSM. THEREFORE, THE DETACHED COIL WAS REMOVED WITH SNARE AND THROMBUS WAS FOUND ON THE COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER REPLACING WITH ANOTHER PRODUCT.

  Patient problems: Thrombus

  MAUDE report 8834802 ↗
• InjuryMay 16, 2018Break; Break

  THE PHYSICIAN FAILED TO FLUSH AND THE COIL BROKE OFF IN THE MICROCATHETER; IT WAS REPORTED THE COIL WAS IN THE PATIENT'S BODY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7519148 ↗
• MalfunctionFeb 14, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT WHEN THE COIL WAS BEING REMOVED INTO THE INTRODUCER SHEATH, THE COIL DETACHED PREMATURELY INSIDE THE MICROCATHETER. THE COIL WAS RETRIEVED WITH A MOSQUITO CLAMP. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6331009 ↗
• InjuryAug 5, 2016Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF AN ACUTE BASILAR TIP UN-RUPTURED ANEURYSM, AFTER PROPERLY PLACING 2 COILS IN THE ANEURYSM, THE 3RD COIL (SUBJECT COIL) WHEN PLACED, DID NOT GO IN FULL LENGTH INTO THE ANEURYSM. THE PHYSICIAN DECIDED TO REPOSITION THE SUBJECT COIL BUT THE COIL MASS WAS MOVING WITH THE MICROCATHETER TIP. THE PHYSICIAN DECIDED TO REMOVE THE 3RD COIL BUT IN THE PROCESS OF REMOVING THE 3RD COIL, THE 3RD COIL BECAME ENTANGLED IN THE COIL MASS, STRETCHED, AND THE DELIVERY WIRE BROKE MID-SHAFT INTO THE PELVIC AREA. THE STRETCHED SUBJECT COIL WAS LEFT IN THE PATIENT. IT WAS ALSO REPORTED THAT THE MICROCATHETER TIP BECAME ENTANGLED IN THE COIL MASS WITHOUT POSSIBILITY TO BE REMOVED. THE MICROCATHETER WAS CUT AT THE PROXIMAL SECTION AND LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED AND NO ADVERSE CONSEQUENCES TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque; Hemorrhage, Subarachnoid; Neurological Deficit/Dysfunction; Stroke/CVA; Thrombosis

  MAUDE report 5851465 ↗
• MalfunctionJun 7, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE PHYSICIAN RETRACTED THE SUBJECT COIL TO DO THE REPOSITIONING AND THE COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE ALL PIECES OF THE COIL (MAIN COIL AND PUSHER WIRE) WERE RETRIEVED WITH THE GUIDECATHETER AND MICROCATHETER AS A WHOLE UNIT. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5704330 ↗