TARGET M0036180620Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327466386), received between May 10, 2022 and Sep 18, 2025 — classified as 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT WHEN AN ATTEMPT WAS MADE TO INSERT SUBJECT COIL INTO A MICROCATHETER, SLIGHT RESISTANCE WAS ENCOUNTERED IN THE SHAFT, THUS, THE SUBJECT COIL WAS CAREFULLY ADVANCED WITHIN THE SHAFT; HOWEVER, THE SUBJECT COIL GOT PREMATURELY DETACHED IN THE MICROCATHETER SHAFT. SINCE THE ANEURYSM WAS COILED ENOUGH, THE PREMATURELY DETACHED COIL WAS REMOVED WITH THE ENTIRE MICROCATHETER, 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 23089276 ↗
• MalfunctionJun 4, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE SUBJECT COIL WAS PREMATURELY DETACHED WHILE ADVANCING IN THE MICROCATHETER. THE SUBJECT COIL WAS REMOVED WITH THE ENTIRE MICROCATHETER, AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. 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 19462523 ↗
• MalfunctionApr 10, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF COMMON HEPATIC ARTERY PROCEDURE, THE SUBJECT COIL WAS PREMATURELY DETACHED AND REMOVED ALONE BY PULLING THE DELIVERY WIRE. THE PROXIMAL PART OF THE SUBJECT COIL WAS FOUND STRETCHED. 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 16710487 ↗
• MalfunctionMay 10, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE IN A PATIENT, THERE WAS RESISTANCE WHEN THE SUBJECT COIL WAS ADVANCED THROUGH THE INTRODUCER SHEATH AND THE SUBJECT COIL GOT STUCK AND DETACHED PREMATURELY DURING DELIVERY INSIDE THE MICROCATHETER IN THE PATIENT'S ANATOMY. THE DETACHED SUBJECT COIL WAS REMOVED FROM THE PATIENT VASCULATURE TOGETHER WITH THE ENTIRE 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 14349334 ↗