TARGET M0035443040Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613252600336), received between Apr 24, 2017 and Jun 30, 2026 — classified as 2 injuries, 5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Fracture; Expulsion

  IT WAS REPORTED THAT DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO DETACH THE SUBJECT COIL, BUT THE SUBJECT COIL FAILED TO DETACH. FORCEFUL TRACTION APPLIED TO SUBJECT COIL DELIVERY WIRE, RESULTED IN BREAKAGE AT THE DISTAL SEGMENT OF THE DELIVERY WIRE. THE DETACHED DISTAL SEGMENT COULD NOT BE RETRIEVED. FOLLOW-UP ANGIOGRAPHY REVEALED SUBJECT COIL PROTRUSION, AND A RESCUE STENT WAS PLACED TO MANAGE THIS COMPLICATION. THE PROCEDURE WAS THEN COMPLETED. THERE WAS A SURGICAL DELAY OF UNKNOWN MINUTES DUE TO THE REPORTED EVENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25669783 ↗
• MalfunctionApr 25, 2023Premature Separation; Premature Separation

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT COIL PREMATURELY DETACHED/SEPARATED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16805218 ↗
• MalfunctionMay 12, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION FOR URGENT GASTROINTESTINAL BLEEDING. AFTER GUIDING THE MICROCATHETER TO THE TARGET SITE, THE COIL (SUBJECT DEVICE) WAS SELECTED AS THE FIRST COIL. AFTER PLACING IT, A SHORT SOUND WAS HEARD THREE TIMES. THE DETACH BUTTON WAS PRESSED AGAIN AND A LONG BEEP SOUNDED, THUS IT WAS DETERMINED THAT THE COIL (SUBJECT DEVICE) WAS DETACHED, AND THE DELIVERY WIRE WAS REMOVED. THE MICROCATHETER GOT DEVIATED WHEN THE COIL (SUBJECT DEVICE) CAME OUT AND DIDN'T DETACH. THE COIL (SUBJECT DEVICE) WAS RETRACTED. THE MICROCATHETER WAS INSERTED AGAIN AND THIS COIL (SUBJECT DEVICE) WAS REUSED, NEVERTHELESS THIS COIL WAS PREMATURELY DETACHED WHILE ADVANCEMENT IN THE MICROCATHETER SHAFT OUTSIDE THE PATIENT. 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 14379942 ↗
• MalfunctionMar 29, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT SUBJECT COIL COMES OFF ITSELF IN THE CATHETER. 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 11586725 ↗
• MalfunctionMar 2, 2021Fracture; Fracture

  ANALYSIS OF THE RETURNED SUBJECT COIL REVEALED THAT THE COIL DELIVERY WIRE HAD BROKEN/FRACTURED DURING USE. THEREFORE, BASED ON THIS INFORMATION THE EVENT IS DEEMED REPORTABLE WITH AN AWARENESS DATE OF (B)(6) 2021. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11400066 ↗
• MalfunctionDec 27, 2018Break; Break

  DURING THE COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE COIL GOT STUCK IN THE MICROCATHETER AND BROKE. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE NOW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8200439 ↗
• InjuryApr 24, 2017Migration or Expulsion of Device; Premature Activation; Migration or Expulsion of Device; Premature Activation

  IT WAS REPORTED THAT AS THE COIL WAS BEING ADVANCED, IT PREMATURELY DETACHED AND MIGRATED. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE COIL BUT WAS UNSUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6517213 ↗