TARGET M0035424080Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540675927), received between Jan 16, 2017 and Dec 18, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT DEVICE WAS BROKEN/FRACTURED DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836085 ↗
• MalfunctionFeb 19, 2025No Visual Prompts/Feedback; No Visual Prompts/Feedback

  IT WAS REPORTED AFTER THE EMBOLIZATION WAS PERFORMED AND THE SUBJECT COIL WAS RELEASED FOR PLACEMENT, IT COULD NOT BE OBSERVED UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED WITH NO CLINICAL CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411909 ↗
• MalfunctionDec 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE MICROCATHETER WAS INSERTED INTO THE ANEURYSM AND THE SUBJECT COIL WAS INSERTED INTO THE MICROCATHETER. THE PHYSICIAN DETACHED THE SUBJECT COIL AND PULLED THE DELIVERY WIRE BUT THE SUBJECT COIL CAME OUT WITH THE DELIVERY WIRE. WHEN THE PHYSICIAN ATTEMPTED TO REINSERT THE SUBJECT COIL INTO THE ANEURYSM, IT FRACTURED INSIDE THE MICROCATHETER. THE MICROCATHETER WAS REMOVED AS THE SUBJECT COIL WAS JAMMED INSIDE AND COULD NOT BE RETRIEVED. THE PHYSICIAN REPLACED BOTH DEVICES WITH NEW DEVICES AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20961970 ↗
• MalfunctionApr 12, 2023Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT COIL BROKE/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16721983 ↗
• MalfunctionDec 9, 2022Fracture; Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE PROXIMAL END OF THE SUBJECT COIL DELIVERY WIRE WAS BROKEN/FRACTURED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15951849 ↗
• MalfunctionAug 8, 2022Migration; Migration

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, PHYSICIAN USED THE COILS BUT THE FIRST COIL WAS UNABLE TO DETACH. THE SUBJECT COIL WAS USED AS THE SECOND COIL AND DETACHED SUCCESSFULLY BUT IT WAS FLOATING FREELY INSIDE THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15189253 ↗
• MalfunctionDec 14, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DELIVERY WIRE OF THE COIL (SUBJECT DEVICE) WAS FOUND TO BE BROKEN. 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 13003245 ↗
• MalfunctionFeb 12, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING WIDE NECK IRREGULAR HEMORRHAGIC ANEURYSM PROCEDURE ON RIGHT POSTERIOR COMMUNICATING ARTERY (PCOMA), THE SEGMENT OF THE SUBJECT COIL DELIVERY WIRE WAS FRACTURED AT ABOUT 1 CM FROM THE COIL AND THE FRACTURED PART OF THE COIL DELIVERY WIRE WAS COVERED/PRESSED BY THE STENT INSIDE THE ANEURYSM INSIDE THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9703581 ↗
• MalfunctionJul 31, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THE COIL (SUBJECT DEVICE) PREMATURELY DEPLOYED INTO THE MICROCATHETER HUB. THE PHYSICIAN REPLACED THE COIL AND COMPLETED THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8848789 ↗
• InjuryJan 16, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING A COIL EMBOLIZATION PROCEDURE, THE COIL STRETCHED AND IT COULD NOT BE REMOVED. IT WAS REPORTED THAT THE PHYSICIAN DEPLOYED A STENT TO SECURE THE STRETCHED PORTION OF THE COIL AGAINST THE VESSEL WALL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6255132 ↗