TARGET M0035431530Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540698049), received between Aug 14, 2017 and May 1, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT THE SUBJECT COIL¿S FLOURO SAVERS WERE ALLEGEDLY MISPLACED. SO, THE SUBJECT COIL WAS ¿ADVANCED¿ INTO THE ANEURYSM BEFORE THE PHYSICIAN WAS AWARE (BECAUSE OF THE MISPLACED MARKERS). THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057138 ↗
• MalfunctionFeb 8, 2024Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE COIL (SUBJECT DEVICE) BROKEN, FRACTURED 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 18669428 ↗
• MalfunctionJul 24, 2023Premature Separation; Premature Separation

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE COIL (SUBJECT DEVICE) WAS PREMATURELY DETACHED INSIDE THE CATHETER. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17385164 ↗
• MalfunctionSep 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE RESISTANCE WAS ENCOUNTERED WHILE THE COIL (SUBJECT DEVICE) WAS BEING ADVANCED WITHIN THE MICROCATHETER AND THE SUBJECT DEVICE WAS FOUND TO BE STRETCHED. THE PHYSICIAN REMOVED THE SUBJECT DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE MAIN COIL (SUBJECT DEVICE) WAS FOUND TO BE 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 15460407 ↗
• MalfunctionNov 8, 2021Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE MAIN COIL BROKEN/FRACTURED. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12776074 ↗
• MalfunctionAug 2, 2019Break; Break

  IT WAS REPORTED THAT WHEN THE COIL (SUBJECT DEVICE) WAS ADVANCED INTO THE MICROCATHETER HUB, THE PHYSICIAN EXPERIENCED DIFFICULTY AND DURING WITHDRAWAL, THE COIL BROKE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8858053 ↗
• MalfunctionJan 3, 2019Break; Break

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, THE DELIVERY WIRE OF THE COIL WAS FRACTURED WHEN ADVANCED THROUGH THE MICROCATHETER. THE COIL WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8215660 ↗
• InjurySep 10, 2018Break; Migration; Break; Migration

  IT WAS REPORTED THAT THE SUBJECT COIL WAS USED AS THE LAST COIL DURING EMBOLIZATION PROCEDURE FOR ANEURYSM LOCATED AT THE ANTERIOR COMMUNICATING ARTERY (ACOM). THE PHYSICIAN HAD DIFFICULTY POSITIONING THE SUBJECT COIL IN THE TARGET LESION. THE PHYSICIAN TRIED MULTIPLE TIMES TO ADJUST THE POSITION OF THE SUBJECT COIL; HOWEVER, THE SUBJECT COIL DELIVERY WIRE BROKE AND WAS FLUSHED TO THE DISTAL OF THE VESSEL WITH THE MAIN COIL AND THE PROCEDURE WAS STOPPED. POST PROCEDURE COMPUTED TOMOGRAPHY (CT) SHOWED THAT THE BROKEN DELIVERY WIRE WAS IN THE VESSEL. A SNARE DEVICE WAS USED DURING THIS PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7860553 ↗
• MalfunctionAug 14, 2017Break; Break

  BASED ON THE RESULT OF THE INVESTIGATION OF THE RETURNED PRODUCT, IT WAS FOUND THAT THE MAIN COIL (SUBJECT DEVICE) WAS BROKEN. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6793568 ↗