TARGET M0036180630Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327466393), received between Nov 28, 2021 and Mar 25, 2026 — classified as 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, DURING COILING PROCESS, THE SUBJECT DEVICE GOT PREMATURELY DETACHED AND WAS REMOVED ALONG WITH THE MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687791 ↗
• MalfunctionApr 9, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING ADVANCEMENT OF THE SUBJECT COIL WITHIN THE MICROCATHETER, THE SUBJECT MAIN COIL GOT PREMATURELY DETACHED IN THE SHAFT. ATTEMPT WAS MADE TO PUSH THE SUBJECT MAIN COIL OUT WITH THE SUBJECT COIL DELIVERY WIRE; HOWEVER, THE SUBJECT MAIN COIL DID NOT MOVE. 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 21809705 ↗
• MalfunctionNov 28, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, A COIL WAS STUCK AT THE HUB OF THE MICROCATHETER AND WAS REPLACED WITH THE SUBJECT COIL. FRICTION WAS REPORTED WHEN MOVING THE SUBJECT COIL INSIDE THE INTRODUCER SHEATH AND INSIDE THE MICROCATHETER. IT WAS REPORTED THAT THE SUBJECT COIL WAS STUCK IN THE SHAFT; AND UPON RETRIEVAL, THE SUBJECT COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN WITHDREW THE WHOLE SYSTEM. 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 12879982 ↗