TARGET XL M0036101650Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540711304), received between Mar 11, 2020 and Apr 4, 2024 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2024Premature Separation; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE COIL (SUBJECT DEVICE) HAD DETACHED PREMATURELY DURING USE. THE PHYSICIAN REPLACED THE SUBJECT COIL WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047188 ↗
• MalfunctionApr 4, 2024Fracture; Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE COIL DELIVERY WIRE (SUBJECT DEVICE) WAS BROKEN/FRACTURED DURING USE. THE PHYSICIAN REPLACED THE SUBJECT COIL WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047187 ↗
• MalfunctionAug 16, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT AFTER DETACHMENT OF THE SUBJECT COIL, WHEN THE DELIVERY WIRE WAS PULLED THINKING THE SUBJECT COIL WAS DETACHED SUCCESSFULLY SINCE THREE BEEP SOUND WAS HEARD. HOWEVER, IT HAD NOT BEEN DETACHED. THEN THE SUBJECT COIL WAS REINSERTED, BUT IT COULD NOT BE OPERATED AS EXPECTED. THE SUBJECT COIL WAS RETRIEVED, AND FOUND IT WAS STRETCHED AND PREMATURELY DETACHED INSIDE 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 17561461 ↗
• InjuryJul 23, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING ENDOVASCULAR COIL EMBOLIZATION PROCEDURE THE SUBJECT COIL WAS PLACED AND WITHDRAWN SEVERAL TIMES (NOT COMPLETELY OUT OF CATHETER) AND THE OPERATOR NOTICED THAT THOUGH THE COIL SEEMS TO BE DISCONNECTED FROM THE PUSHER WIRE, IT IS STILL IN CATHETER. SO THE OPERATOR CUT OFF THE CATHETER AT THE HUB AND A SNARE IS PULLED OVER IT. DUE TO THE CURVED VASCULAR ANATOMY, ATTEMPT TO SALVAGE WITH SNARE FAILED. THE CATHETER WAS WITHDRAWN WITH THE SUBJECT COIL IN PLACE AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222257 ↗
• MalfunctionFeb 5, 2021Expulsion; Expulsion

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE PULLING BACK THE SUBJECT COIL FROM INSIDE THE MICRO CATHETER. THE PHYSICIAN FELT THAT THE COIL WAS OVERSIZED INSIDE THE ANEURYSM AND PROTRUDING INTO PARENT VESSEL. THE SUBJECT COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S ANATOMY. 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 11290082 ↗
• MalfunctionMar 30, 2020Stretched; Premature Separation; Stretched; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL STRETCHED WHEN THE PHYSICIAN TRIED TO RETRIEVE THE COIL OUT OF THE ANEURYSM. WHILE REMOVING, THE SUBJECT COIL DETACHED INSIDE THE MICROCATHETER. THE DEVICES WERE REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897338 ↗
• MalfunctionMar 11, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE COIL (SUBJECT DEVICE) COULDN'T BE DELIVERED OUT OF MICROCATHETER AND THEN THE COIL (SUBJECT DEVICE) DETACHED UNEXPECTEDLY DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND FINISH THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9821407 ↗