TARGET M0035461540Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252192534), received between Feb 22, 2019 and Mar 30, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Premature Separation

  IT WAS REPORTED THAT THE SUBJECT MAIN COIL FAILED TO DETACH. THE PHYSICIAN TIRED MORE THAN 8 TIMES WITH TWO DIFFERENT POWER SUPPLIES. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT COIL WAS PREMATURELY DETACHED/SEPARATED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730483 ↗
• MalfunctionAug 3, 2022Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT COIL WAS FOUND PREMATURELY DEPLOYED 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 15156442 ↗
• MalfunctionJun 21, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT CEREBRAL COILING PROCEDURE WAS PERFORMED TO TREAT CAROTICOCAVERNOUS FISTULA IN A PATIENT. THE SUBJECT COIL WAS THE THIRD COIL USED IN THE PROCEDURE. DURING THE PROCEDURE THE SUBJECT COIL WAS ADVANCED THROUGH A MICROCATHETER WITHOUT ANY RESISTANCE. BEFORE DETACHMENT OF THE SUBJECT COIL THE PHYSICIAN CHECKED FOR THE POSITION OF THE SUBJECT COIL AND NOTICED THAT PART OF THE SUBJECT COIL WAS WITHIN THE MIDDLE OF THE CEREBRAL ARTERY. THEREFORE THE PHYSICIAN DECIDED TO SLOWLY RETRIEVE, READJUST AND REDEPLOY THE SUBJECT COIL WITHIN THE TARGET LESION. DURING THIS ATTEMPT OF REDEPLOYMENT THE PHYSICIAN NOTICED THAT THE LAST FEW CENTIMETERS OF THE SUBJECT COIL WAS NOT RESPONDING TO ANY PUSH OR PULL MOTION. THE PHYSICIAN DECIDED TO RETRIEVE THE SUBJECT COIL AND NOTICED IT HAD BEEN DETACHED. THE PHYSICIAN THEN REMOVED THE SUBJECT COIL ALONG WITH THE MICROCATHETER OUT OF THE PATIENT'S VASCULATURE. 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 14757476 ↗
• InjuryFeb 22, 2019Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN TRIED TO RESHEATH AND REMOVE THE SUBJECT COIL FROM THE PATIENT¿S ANATOMY; HOWEVER, THE SUBJECT COIL WAS STRETCHED AND BROKEN. THE PHYSICIAN WAS ABLE TO REMOVE THE BROKEN COIL USING A STENT RETRIEVER FROM THE PATIENT ANATOMY. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. NO KNOWN PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8363158 ↗