TARGET XL M0036121650Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540711557), received between Mar 20, 2019 and May 6, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE MAIN COIL (SUBJECT DEVICE) WAS SEEN TO BE FRACTURED NEAR THE DETACHMENT ZONE. 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 25096170 ↗
• MalfunctionFeb 13, 2026Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL WAS INITIALLY ADVANCED INTO THE MICROCATHETER WHILE THE COIL'S SHEATH WASN'T FULLY SEATED AGAINST THE HUB. A FEW LOOPS HAD ALREADY BEEN DEPLOYED IN THE MICROCATHETER. THE SUBJECT COIL WAS CAREFULLY PULLED BACK INTO THE SHEATH. THE SUBJECT COIL WAS REINSERTED INTO THE MICROCATHETER AND ADVANCED. THE SUBJECT COIL WAS VISIBLE UNDER FLUOROSCOPY, BUT IT WAS NOT OUT OF MICROCATHETER. THE SUBJECT COIL WAS FOUND TO BE DETACHED. THE SUBJECT COIL 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 24338434 ↗
• InjuryNov 6, 2024Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE THE SUBJECT COIL PREMATURELY DETACHED FROM THE PUSHER WIRE INSIDE THE CATHETER. THE COIL WAS REMOVED FROM THE CATHETER WITH A MICRO SNARE. THERE WAS A SURGICAL DELAY OF UNKNOWN TIME. THE PATIENT WAS NOT AFFECTED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623649 ↗
• InjuryMay 10, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE TREATMENT OF RIGHT CAROTID-CAVERNOUS FISTULA, THE OPERATOR USED THE MICROCATHETER AND THE GUIDEWIRE TO NAVIGATE TO THE INTERIOR OF THE FISTULOUS ORIFICE. DURING THE POSITIONING OF THE SUBJECT COIL, IT DETACHED PREMATURELY AND THE STENT RETRIEVER WAS USED TO CAPTURE IT. A 30 MINUTES SURGICAL DELAY WAS REPORTED DUE TO THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19294350 ↗
• MalfunctionJan 21, 2022Fracture; Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE COIL DELIVERY WIRE BROKEN/FRACTURED DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13312408 ↗
• MalfunctionMar 20, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL REDEPLOYED IN THE CATHETER . NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8438485 ↗