TARGET XL M0036122060Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327128260), received between Apr 9, 2020 and May 23, 2024 — classified as 2 injuries, 9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PULMONARY ARTERIOVENOUS MALFORMATION (AVM) PROCEDURE THE SUBJECT COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER AND WAS REMOVED WITH THE SNARE DEVICE. 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 19387690 ↗
• InjuryFeb 8, 2024Expulsion; Expulsion

  IT WAS REPORTED THAT DURING PROCEDURE AFTER DEPLOYMENT OF THE SUBJECT COIL DEVICE, THE SUBJECT COIL WAS PROTRUDING INTO THE NECK OF THE ANEURYSM AS THERE WAS CONCERN FOR COMPROMISE FLOW TO THE MCA (MIDDLE CEREBRAL ARTERY) VASCULATURE. THEREFORE, THE STENT WAS IMPLANTED TO SUPPORT THE SUBJECT PROTRUDING COIL AND THE MEDICATION WAS ADMINISTERED TO THE PATIENT. THE LAST VISIT WAS FOR THE 12-MONTH FOLLOW UP, CONDUCTED ON (B)(6) 2023, AND THE PATIENT HAD MRS (MODIFIED RANKIN SCALE) AND NIHSS (NATIONAL INSTITUTE OF HEALTH STROKE SCALE) SCORE OF 0.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668820 ↗
• MalfunctionJul 21, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WHICH WAS INSERTED AS THE TENTH COIL OUT OF THIRTEEN, WAS DIFFICULT TO ENGAGE IN THE ANEURYSM AND THE PHYSICIAN HAD TO REPOSITION IT SEVERAL TIMES. WHEN THE PHYSICIAN ATTEMPTED TO RETRIEVE THE SUBJECT COIL, IT WAS CONFIRMED THAT THE SUBJECT COIL PREMATURELY DETACHED WITHIN THE MICROCATHETER AND COULD NOT BE REMOVED. THE SUBJECT COIL WAS PUSHED INTO THE ANEURYSM WITH THE NEXT COIL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SAME MICROCATHETER. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17373477 ↗
• MalfunctionJan 20, 2023Fracture; Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE COIL (SUBJECT DEVICE) DELIVERY WIRE 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 16218716 ↗
• MalfunctionJan 19, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING ISOLATION OF A PSEUDOSPLENIC ANEURYSM PROCEDURE, WHEN INSERTED THE COIL (SUBJECT DEVICE) INTO A NON-STRYKER MICROCATHETER, CARNELIAN HF, AND WHEN PUSHING AND PULLING WAS PERFORMED TO ENGAGE WITH THE VESSEL REPEATEDLY, THE COIL (SUBJECT DEVICE) GOT PREMATURELY DETACHED (DETACHED POSITION IS UNKNOWN). THEREFORE, THE COIL (SUBJECT DEVICE) RETRIEVED WITH THE ENTIRE MICROCATHETER. 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 16209964 ↗
• MalfunctionSep 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL (SUBJECT DEVICE) FELT RESISTANCE WITHIN THE MICROCATHETER AND WAS UNABLE TO BE DEPLOYED. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE MAIN COIL (SUBJECT DEVICE) WAS FOUND TO BE BROKEN/FRACTURED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446434 ↗
• MalfunctionJun 4, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE, THE RESISTANCE ENCOUNTERED WHEN ADVANCING THE COIL (SUBJECT DEVICE) IN THE INTRODUCER SHEATH, IN THE HUB OF THE MICROCATHETER AND IN THE MICROCATHETER. THE COIL (SUBJECT DEVICE) WAS PREMATURELY DETACHED WITHIN THE MICROCATHETER. THE DETACHED COIL (SUBJECT DEVICE) COULD BE REMOVED BY RETRIEVING THE ENTIRE MICROCATHETER. NO FRAGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE COIL (SUBJECT DEVICE) AND THE MICROCATHETER. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599391 ↗
• MalfunctionMar 17, 2022Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THE MAIN COIL PREMATURELY DETACHED/ SEPARATED FROM DELIVERY WIRE 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 13795913 ↗
• MalfunctionFeb 22, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE COIL (SUBJECT DEVICE) WAS INSERTED INTO THE MICROCATHETER IT DID NOT WIND WELL AT THE TREATMENT SITE AND WHEN IT WAS PULLED BACK TO RETRIEVE IT, THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED. THE COIL (SUBJECT DEVICE) WAS RETRIEVED ALONG WITH THE MICROCATHETER. THE DETAILS OF THE IMMEDIATE ACTION TAKEN ARE UNKNOWN. 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 13579709 ↗
• MalfunctionJan 27, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) ENCOUNTERED RESISTANCE WHILE WAS ADVANCING THE INTRODUCER SHEATH AND IT GOT STUCK AT THE DISTAL OF THE MICROCATHETER, THERE WAS FEELING THAT THE COIL (SUBJECT DEVICE) GOT KINKED. THEREFORE, AN ATTEMPT WAS MADE TO RETRIEVE THE COIL (SUBJECT DEVICE). HOWEVER, IT WAS PREMATURELY DETACHED INSIDE 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 13375902 ↗
• MalfunctionApr 9, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION FOR COLLATERAL CIRCULATION PROCEDURE, FOR ANCHORING, WHEN THE COIL(SUBJECT DEVICE) WAS INSERTED INTO THE MICRO CATHETER, AND WAS PUSHED OR PULLED INTO THE BLOOD VESSEL, THE COIL PREMATURELY DETACHED INSIDE THE MICRO CATHETER. THE PHYSICIAN PUSHED THE SUBJECT COIL WITH A GUIDE WIRE AND RETRACTED THE COIL ALONG WITH THE MICRO CATHETER OUTSIDE THE PATIENT'S ANATOMY, AND THEN REMOVED THE COIL FROM THE MICRO CATHETER. THE PHYSICIAN REPLACED THE COIL WITH A NEW ONE AND COMPLETED THE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9946925 ↗