Target M0035434080Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540676115), received between Sep 3, 2021 and Feb 13, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING DETACHMENT PROCEDURE, THE PROXIMAL END OF THE SUBJECT COIL DELIVERY WIRE WAS FOUND BROKEN DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696033 ↗
• InjuryAug 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACA (ANTERIOR CEREBRAL ARTERY) ANEURYSM CASE. AFTER INSERTING THREE COILS, THE OPERATOR DELIVERED THE FOURTH SUBJECT COIL AND DISTAL OF THE SUBJECT COIL GOT STUCK IN MICROCATHETER. WHEN THE OPERATOR MANIPULATE THE SUBJECT COIL FROM PROXIMAL, THE REACTION FROM DISTAL BECAME WEAKER. CONTINUED TO FILL AND AFTER DISTAL OF THE SUBJECT COIL WENT INTO ANEURYSM, THE OPERATOR FOUND THE DISTAL COULD NOT FOLLOW THE PROXIMAL MANIPULATION. WITHDREW THE DELIVERY WIRE SLIGHTLY AND FOUND THE SUBJECT COIL FRACTURED AT THE SEGMENT THAT IS NOT THE DETACHMENT ZONE. THE OPERATOR USED GUIDEWIRE AS A MEDICAL INTERVENTION TO PUSH THE RESIDUAL OF THE SUBJECT COIL TO GO INTO ANEURYSM INSIDE THE MICROCATHETER TO FINISH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE PATIENT IS ALREADY WAKE UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557448 ↗
• MalfunctionJun 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT AT THE TIME OF RELEASE THE COIL (SUBJECT DEVICE), IT WAS PARTIALLY RELEASED, REMAINING ADHERED TO THE DELIVERY SYSTEM, WHICH WAS LEFT OUTSIDE THE ANEURYSMAL SAC, RUPTURING BETWEEN THE STRUTS OF THE STENT AND THE VESSEL WALL. 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 17119173 ↗
• MalfunctionFeb 21, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT A ANEURYSMAL COIL EMBOLIZATION PROCEDURE WAS PERFORMED IN INTERNAL CAROTID ARTERY IN A PATIENT. DURING THE PROCEDURE WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE SUBJECT COIL THROUGH THE MICROCATHETER, THE PHYSICIAN FELT RESISTANCE AND THE SUBJECT COIL DETACHED PREMATURELY IN THE PROXIMAL PART OF THE MICROCATHETER. THE SUBJECT COIL WAS 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 13573323 ↗
• MalfunctionSep 3, 2021Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE COIL (SUBJECT DEVICE) WAS BROKEN/FRACTURED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425038 ↗