TARGET XL M0036101450Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04546540711298), received between Aug 8, 2016 and Oct 7, 2025 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2025Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE THE SUBJECT COIL WAS PREMATURELY DETACHED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23233084 ↗
• MalfunctionMay 7, 2024Fracture; Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE COIL (SUBJECT DEVICE) WAS FRACTURED DURING USE. 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 19261225 ↗
• MalfunctionJul 25, 2023Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE MAIN COIL (SUBJECT DEVICE) WAS PREMATURELY DETACHED 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 17390680 ↗
• MalfunctionJun 6, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL DETACHED DURING THE PROCEDURE WHEN AN ATTEMPT WAS MADE TO RETRACT IT INTO THE MICROCATHETER TO REPOSITION THE SUBJECT COIL. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14603170 ↗
• MalfunctionMay 22, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED INSIDE THE CATHETER. THE COIL WAS REMOVED AND THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10083821 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SUBJECT COIL AND THE COIL BECAME STRETCHED INSIDE THE MICROCATHETER SHAFT. THE SUBJECT COIL WAS PULLED BACK WITH A GOOSENECK SNARE. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8801912 ↗
• MalfunctionSep 6, 2018Break; Break

  BASED ON THE INVESTIGATION OF THE RETURNED PRODUCT (SUBJECT DEVICE), IT WAS FOUND THAT THE MAIN COIL WAS BROKEN. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7853259 ↗
• MalfunctionAug 1, 2018Premature Separation; Premature Separation

  IT WAS REPORTED THAT WHEN THE SUBJECT COIL HAD DETACHED PREMATURELY INSIDE THE MICROCATHETER. 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 7741455 ↗
• MalfunctionJan 4, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT WHEN THE COIL WAS ATTEMPTED TO REPOSITIONED, THE COIL DETACHED PREMATURELY INSIDE THE MICROCATHETER. 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 6221943 ↗
• MalfunctionDec 8, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF A LIENAL ARTERY ANEURYSM, FRICTION WAS EXPERIENCED AS THE COIL (SUBJECT DEVICE) WAS ADVANCED INSIDE THE MICROCATHETER. THE COIL EVENTUALLY BECAME JAMMED AT ABOUT 4CM FORM THE PROXIMAL PART OF THE MICROCATHETER. WHILE CONTINUING TO ADVANCE THE COIL FURTHER, THE DELIVERY WIRE WAS BENT AND THE COIL WAS DETACHED AT THE DETACHMENT ZONE INSIDE THE MICROCATHETER. THE COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT¿S BODY AS ONE UNIT. NO IMPACT TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6156027 ↗
• MalfunctionOct 31, 2016Break; Premature Activation; Break; Premature Activation

  ANALYSIS OF THE RETURNED COIL REVEALED THAT THE MAIN COL WAS BROKEN AT MULTIPLE LOCATIONS AND APPEARED TO HAVE PREMATURELY SEPARATED PHYSICALLY AT THE DETACHMENT ZONE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6067908 ↗
• InjurySep 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF AN ACUTE RUPTURED BASILAR TIP GIANT ANEURYSM WITH ACUTE BASILAR SUBARACHNOID HEMORRHAGE (SAH), AFTER PROPERLY PLACING 2 COILS (SUBJECT DEVICE) IN THE ANEURYSM, THE 3RD COIL WHEN PLACED, DID NOT GO IN FULL LENGTH INTO THE ANEURYSM BECAUSE THE COIL LOOPS WERE COMING OUT. THE PHYSICIAN DECIDED TO REPOSITION THE 3RD 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 COIL, THE COIL BECAME ENTANGLED IN THE COIL MASS, STRETCHED, AND THE DELIVERY WIRE BROKE MID-SHAFT INTO THE PELVIC AREA. THE STRETCHED 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. BASILAR THROMBUS FORMED. INJECTION OF PLATELET AGGREGATION INHIBITOR DISSOLVED THE THROMBUS DOWNSTREAM TO THE POSTERIOR CEREBRAL ARTERY (PCA) VESSELS. ON MAGNETIC RESONANCE IMAGING (MRI) IT WAS SEEN THAT THE PCA VESSEL AREAS WERE INFARCTED ON BOTH SIDES AND THERE WAS A SMALL LEFT SIDE BRAIN STEM INFARCT. ACCORDING TO THE PHYSICIAN.

  Patient problems: Neurological Deficit/Dysfunction; Stroke/CVA; Thrombosis

  MAUDE report 5982080 ↗
• MalfunctionAug 8, 2016Break; Break

  IT WAS REPORTED THAT DURING THE EMBOLIZATION PROCEDURE THE SUBJECT DEVICE ENCOUNTERED A LOT OF RESISTANCE WHEN WAS ADVANCED THROUGH THE MICROCATHETER. AFTER PLACEMENT INTO THE ANEURYSM THE DEVICE WAS UNABLE TO BE DETACHED AND PHYSICIAN HAS DECIDED TO RETRACT THE COIL. DURING THE RETRIEVAL THE MAIN COIL BROKE, HAVING A THIN FILAMENT ATTACHED TO THE COIL THAT MADE SAFE AND COMPLETE REMOVAL OF THE BROKEN DEVICE FROM THE PATIENT POSSIBLE. THERE WAS NO CLINICAL CONSEQUENCE REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5854843 ↗