TARGET M0035473510Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540714770), received between Sep 24, 2018 and Oct 17, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Premature Separation; Premature Separation

  IT WAS REPORTED DURING PROCEDURE; THE SUBJECT COIL WAS STUCK IN THE MIDDLE OF MICROCATHETER AS THE SUBJECT COIL COULD NOT BE PUSHED FORWARD AND THE SUBJECT COIL WAS PREMATURELY DETACHED IN THE HALF BODY OF THE MICROCATHETER. THE SUBJECT COIL WAS REMOVED AND REPLACED WITH A NEW COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324374 ↗
• MalfunctionFeb 19, 2021Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE SUBJECT COIL WAS SLIGHTLY VISIBLE UNDER FLUOROSCOPY. THE PHYSICIAN REMOVED THE SUBJECT COIL FROM THE PATIENT ANATOMY AND REPLACED IT WITH A SIMILAR DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL COMPLICATIONS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11355782 ↗
• InjuryDec 28, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING THE COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE FIRST COIL (SUBJECT DEVICE) WAS IMPLANTED SUCCESSFULLY. THEN SECOND COIL ENCOUNTERED RESISTANCE WHEN ADVANCING IN THE DISTAL TIP OF MICROCATHETER AND WAS REMOVED. AND THEN THE THIRD COIL ALSO ENCOUNTERED RESISTANCE WHEN ADVANCING IN THE DISTAL TIP OF THE MICROCATHETER AND THE PHYSICIAN DECIDED TO REMOVE IT. HOWEVER, DURING THE REMOVAL OF THE THIRD COIL, THE FIRST COIL WAS SOMEHOW BEING RETRACTED INTO THE MICROCATHETER AND EVERYTHING GOT STUCK. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE MICROCATHETER AND HOPING THE COILS WOULD COME WITH THE MICROCATHETER TOGETHER. UNFORTUNATELY, THE FIRST COIL WAS LOOSE FROM THE MICROCATHETER AND PART OF THE COIL WAS PROTRUDED TO THE PARENT VESSEL. FINALLY, THE PHYSICIAN REMOVED THE FIRST COIL FROM THE PATIENT WITH THE STENT RETRIEVER AFTER SEVERAL ATTEMPTS. THUS, THE PROCEDURE WAS STOPPED, AND THE PATIENT WAS GOING TO BE SURGICALLY CLIPPED INSTEAD OF COILING. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE FOR NOW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8204952 ↗
• MalfunctionSep 24, 2018Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE RO (RADIO OPAQUE) MARKER OF THE COIL (SUBJECT DEVICE) DELIVERY WIRE WAS MISALIGNED AND POSSIBLY INCORRECT IN LENGTH WHEN UNDER OBSERVED UNDER FLUOROSCOPY DURING THE PROCEDURE. THE PHYSICIAN CONTINUED THE PROCEDURE AND DETACHED THE COIL SUCCESSFULLY WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7903150 ↗