TARGET M0035423080Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540675897), received between Sep 7, 2017 and May 22, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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.

• MalfunctionMay 22, 2026Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SUBJECT COIL HAD SUTURE DAMAGE, IT WAS STRETCHED AND WAS BROKEN/FRACTURED DURING USE. ALSO, THE DELIVERY WIRE AND THE PROXIMAL CONTACT OF THE SUBJECT COIL WAS KINKED/BENT. THE SUBJECT DEVICE WAS REPORTED TO BE REPLACED, AND THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257268 ↗
• MalfunctionSep 27, 2024Premature Separation; Premature Separation

  DURING COIL EMBOLIZATION OF RUPTURED ANEURYSM PROCEDURE, THE SUBJECT COIL ENCOUNTERED RESISTANCE WHEN BEING ADVANCED WITHIN THE MICROCATHETER. THE OPERATOR ATTEMPTED TO WITHDRAW THE SUBJECT COIL BUT IT GOT PREMATURELY DETACHED. THE SUBJECT DEVICE 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 20322696 ↗
• MalfunctionMay 26, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE IN A PATIENT WITH INTERNAL CAROTID ARTERY ICA ANEURYSM, AFTER INSERTING THE SUBJECT COL, THE OPERATOR COULDN'T DETACH IT. SO WITHDREW THE SUBJECT COIL OUT AND FOUND SUBJECT COIL DELIVERY WIRE WAS BROKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015364 ↗
• MalfunctionMar 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE ANEURYSM PROCEDURE USED A GUIDE CATHETER AND GUIDEWIRE TO BRING THE MICROCATHETER TO THE TARGET SITE. PHYSICIAN DEPLOYED THE STENT IN THE TARGET SITE AND STARTED FILLING THE COILS IN THE ANEURYSM WHEN DELIVERING THE SUBJECT COIL TO THE TREATMENT SITE, THE PROXIMAL SECTION OF THE DELIVERY WIRE WAS FRACTURED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759058 ↗
• MalfunctionApr 8, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE EMBOLIZATION OF A RUPTURED ANEURYSM THE SUBJECT COIL BROKE INSIDE THE MICRO CATHETER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11638396 ↗
• MalfunctionApr 8, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE EMBOLIZATION OF A RUPTURED ANEURYSM THE SUBJECT COIL WAS JAMMED IN THE BASEPLATE AND IT BROKE OF IN THE SHEATH. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11638338 ↗
• InjuryMay 1, 2020Expulsion; Premature Separation; Expulsion; Premature Separation

  IT WAS REPORTED THAT DURING EMBOLIZATION PROCEDURE AT POSTERIOR COMMUNICATING ARTERY, THE SUBJECT COIL PROTRUDED TO PARENT VESSEL, THE PHYSICIAN TRIED TO ADJUST THE COIL SEVERAL TIMES AND THE PROXIMAL AREA OF THE COIL GOT STRETCHED, THEN THE PHYSICIAN TRIED TO WITHDRAW THE COIL AND FOUND THE COIL WAS PREMATURELY DETACHED. THE PHYSICIAN USED A GUIDEWIRE TO GUIDE MICROCATHETER TO PASS THE LESION AND DEPLOYED A STENT TO PRESS THE STRETCHED COIL. THE GUIDEWIRE WAS UNABLE TO ADVANCE EVEN AFTER TWISTED TO ADJUST. THE PHYSICIAN WITHDREW THE GUIDEWIRE AND FOUND IT FRACTURED. THEN THE PHYSICIAN USED A SNARE DEVICE TO TAKE THE DETACHED COIL(SUBJECT DEVICE) AND ALONG WITH THE GUIDEWIRE AND COMPLETED THE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10018121 ↗
• MalfunctionJan 10, 2019Break; Break

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE COIL FAILED TO DETACH. THE OPERATOR TRIED TO USE ANOTHER DETACHMENT DEVICE TO DETACH IT BUT FAILED. SO THE OPERATOR WITHDREW THE COIL AND FOUND TIP OF THE COIL DROPPED IN MICROCATHETER. THE PROCEDURE WAS COMPLETED USING OTHER DEVICES. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8238541 ↗
• MalfunctionDec 17, 2018Premature Separation; Premature Separation

  DURING THE COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE 8TH COIL (SUBJECT DEVICE) COULD NOT BE DETACHED. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE COIL. HOWEVER, THE COIL WAS MECHANICALLY DETACHED IN THE MICROCATHETER DURING REMOVAL. SO THE PHYSICIAN USED A GUIDEWIRE TO PUSH THE COIL INTO THE ANEURYSM. AFTER THAT, SEVEN COILS WERE DEPLOYED IN THE ANEURYSM AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8171680 ↗
• InjurySep 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM LOCATED IN THE BASILAR ARTERY APEX. THE PATIENT WAS NEUROLOGICALLY ASSESSED AS HAVING POST-PROCEDURE A MRS OF 1 AND NIHSS 0. IT WAS REPORTED THAT 5-DAY POST-PROCEDURE THE PATIENT NOTICED A BRIGHT "JELLY" TYPE LIGHT IN BOTH EYES. THE ADVERSE EVEN WAS RESOLVED WITHOUT RESIDUAL EFFECTS. 10 DAYS POST-PROCEDURE, THE PATIENT REPORTED A SIMILAR EPISODE OF VISUAL DISTURBANCE IN THE LEFT EYE DESCRIBED AS A BRIGHT LIGHT AT THE BOTTOM OF HER VISUAL FIELD THAT LASTED FOR 5 MINUTES. MRI WAS UNDERTAKEN AND MRI IMPRESSION WERE NEGATIVE (NO INTRACRANIAL ARTERIAL STENOSIS OR INFARCTION IDENTIFIED). ACCORDING TO THE PHYSICIAN, THE VISUAL DISTURBANCE WAS PROBABLY RELATED TO THE PROCEDURE, STENT, AND UNKNOWN IF RELATED TO THE IMPLANTED COILS (SUBJECT DEVICES). THE PATIENT WAS NEUROLOGICALLY ASSESSED AS HAVING A MRS OF 0 AT 2-MONTHS, A NIHSS AND MRS OF 0 AT 6 AND 12 MONTHS FOLLOW-UP POST THE INDEX PROCEDURE.

  Patient problems: Visual Disturbances

  MAUDE report 6850744 ↗