TARGET M0036182050Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327128345), received between Oct 17, 2018 and Jun 15, 2026 — classified as 1 injury, 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Premature Separation

  IT WAS REPORTED THAT WHILE ADVANCING THE SUBJECT COIL WITHIN THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED IN THE MIDDLE OF THE SHAFT, MAKING FURTHER ADVANCEMENT DIFFICULT. WHEN AN ATTEMPT WAS MADE TO RETRIEVE THE SUBJECT COIL, IT BECAME PREMATURELY DETACHED WITHIN THE SHAFT. THEREFORE, BOTH DEVICES WERE REMOVED FROM THE BODY AND REPLACED WITH NEW ONES OF THE SAME TYPE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 25505622 ↗
• MalfunctionFeb 16, 2026Premature Separation

  IT WAS REPORTED THAT DURING THE EMBOLIZATION PROCEDURE OF THE LEFT GONADAL VEIN, THE PHYSICIAN OBSERVED THAT THE SUBJECT COIL WAS NOT POSITIONING PROPERLY. THE PHYSICIAN TRIED TO RETRIEVE THE SUBJECT COIL UNDER FLUOROSCOPY, BUT THE SUBJECT MAIN COIL WAS PREMATURELY DETACHED. THE SUBJECT COIL WAS RETRIEVED AND 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 24350306 ↗
• MalfunctionMar 27, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE THERE WAS RESISTANCE WHEN THE SUBJECT COIL WAS ADVANCED THROUGH THE INTRODUCER SHEATH AND SHAFT OF MICROCATHETER AND THE SUBJECT COIL GOT PREMATURELY DETACHED WITHIN THE MICROCATHETER DURING ADVANCEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21712988 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE 4 COILS (SUBJECT DEVICE) WERE IMPLANTED. POST PROCEDURE, THE PATIENT SUFFERED SEVERE HEADACHE & INCREASING COMPRESSION SYMPTOMS (ABDUCENS NERVE). THREE WEEK CORTISONE THERAPY WAS PRESCRIBED TO CURE THE ADVERSE EVENT AND THE ADVERSE EVENT OF HEADACHE WAS RESOLVED IN 5 DAYS.

  Patient problems: Headache; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14109859 ↗
• MalfunctionSep 17, 2019Break; Break

  IT WAS REPORTED THAT WHEN ADVANCING THE SUBJECT 5TH COIL THROUGH THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED AND THE COIL GOT STUCK; THEREFORE, THE COIL WAS REMOVED. UPON REMOVAL FROM THE MICROCATHETER, THE SUBJECT COIL WAS BROKEN. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9079072 ↗
• MalfunctionJun 4, 2019Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL WAS PREMATURELY DETACHED INSIDE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8667404 ↗
• MalfunctionOct 25, 2018Break; Break

  IT WAS REPORTED THAT WHEN THE SUBJECT COIL WAS RETRIEVED BECAUSE THE SUBJECT COIL SIZE DID NOT MATCH ANEURYSM, IT WAS STUCK IN THE HUB OF THE MICROCATHETER AND IT WAS BROKEN. THEREFORE, IT WAS CHANGED THE NEW SAME ONE AND THE OPERATION WAS CONTINUED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8007178 ↗
• MalfunctionOct 17, 2018Break; Break

  IT WAS REPORTED THAT THE SUBJECT DEVICE COIL WAS BROKEN DURING INSERTION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7976038 ↗