Target M0036154080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540711670), received between Jun 7, 2022 and Sep 13, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (1 report).

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. How this data works · Data updated Oct 13, 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.

• InjurySep 13, 2024Migration; Migration

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE FOR A 4 MM ANEURYSM WAS ABOUT TO BE TREATED WITHOUT A STENT. A MICROCATHETER WAS GUIDED INTO THE ANEURYSM, AND THE FIRST COIL (SUBJECT DEVICE) AND SECOND COIL WERE IMPLANTED. HOWEVER, DURING THE INSERTION OF THE THIRD, IT DID NOT ENGAGE WITH THE MASS, AND WHILE REPOSITIONING THE THIRD COIL, IT BECAME ENTANGLED WITH NEAR THE TIP OF THE FIRST SUBJECT COIL IMPLANTED AND MADE A KNOT, MAKING IT IMPOSSIBLE TO RETRIEVE THE THIRD COIL. WHILE PUSHING AND PULLING THE THIRD COIL TO UNTIE THE KNOT, THE SUBJECT COIL DEVIATED FROM THE MASS, AND A STENT THAT WAS NOT PLANNED TO USE HAD TO BE USED. BY PUSHING AND PULLING THE COILS, THE KNOT WAS UNTIED, AND THE THIRD COIL WAS MANAGED TO BE RETRIEVED. THREE ADDITIONAL COILS WERE INSERTED INTO THE ANEURYSM AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. HOWEVER, AS A STENT WAS USED, THE PATIENT WILL REQUIRE LONG-TERM MEDICATION. THE EXTENDED OPERATIVE TIME ALSO RESULTED IN INCREASED RADIATION EXPOSURE. THE PATIENT¿S CURRENT CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212871 ↗
• MalfunctionJan 5, 2024Premature Separation; Premature Separation

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE MAIN COIL PREMATURELY DETACHED/SEPARATED DURING USE. 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 18457366 ↗
• MalfunctionJun 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN PLACED THE COIL (SUBJECT DEVICE) INTO THE ANEURYSM. THE PROXIMAL PART OF DELIVERY WIRE OF THE SUBJECT COIL BROKE AND THE PHYSICIAN WAS UNABLE TO DETACH THE SUBJECT COIL. THE PHYSICIAN REMOVED THE SUBJECT COIL FROM THE PATIENT ANATOMY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14617796 ↗