TARGET M0035423100Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04546540675903), received between Jul 29, 2016 and Apr 14, 2026 — classified as 5 injuries, 12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Fracture

  IT WAS REPORTED THAT DURING A LEFT POSTERIOR COMMUNICATING ARTERY (PCOMA) ANEURYSM COIL EMBOLIZATION PROCEDURE, WHEN THE SUBJECT COIL WAS PUSHED TO APPROXIMATELY THE HALFWAY POINT OF THE MICROCATHETER, THE PHYSICIAN FOUND THAT IT COULD NOT BE ADVANCED FURTHER. WHEN WITHDRAWN OUTSIDE THE BODY, THE PHYSICIAN FOUND THAT THE COIL HAD BEEN STRETCHED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT MAIN COIL 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 24868058 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT POST PROCEDURE, PATIENT EXPERIENCED WITH TIA (TRANSIENT ISCHEMIC ATTACK). THE PATIENT WAS ADMINISTERED WITH MEDICATION AND THE OUTCOME WAS RESOLVED, WITHOUT SEQUELAE. PATIENT WAS RETURNED TO BASELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Transient Ischemic Attack

  MAUDE report 21964813 ↗
• MalfunctionApr 18, 2024Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL (SUBJECT DEVICE) WAS BROKEN/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 19140087 ↗
• InjuryFeb 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A ANEURYSM EMBOLIZATION CASE, WHEN THE OPERATOR TRIED TO WITHDRAW THE SUBJECT COIL, THE SUBJECT COIL ENCOUNTERED RESISTANCE AS THE SUBJECT COIL GOT TANGLED WITH OTHER COILS PRESENT IN THE ANEURYSM. WHILE DOING SO THE COIL STRETCHED AND FRACTURED DURING THE PROCEDURE. THE OPERATOR USED A STENT TO REMOVE THE STRETCHED AND FRACTURED PART OF THE SUBJECT COIL AND DEPLOYED THE SAME STENT TO COVER THE REST OF THE SUBJECT COIL TO THE VESSEL WALL AND FINISHED THE PROCEDURE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16301684 ↗
• MalfunctionNov 15, 2022Premature Separation; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT COIL HAD PREMATURELY DETACHED/SEPARATED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15796600 ↗
• MalfunctionSep 24, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12528495 ↗
• MalfunctionApr 14, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT WHEN THE PHYSICIAN TRIED TO PLACE THE SUBJECT COIL WITH THE MICROCATHETER, BUT WHEN THE DETACHMENT PERFORMED USING DETACHMENT SYSTEM, THE SUBJECT COIL COULD NOT BE DETACHED AT THE FIRST TIME, SO THE PHYSICIAN TRIED TO DETACH AGAIN (PERFORMED A LONG BEEP TWICE). WHEN THE DELIVERY WIRE WAS PULLED, THE SUBJECT COIL WAS DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN TRIED TO PUSH IT WITH THE DELIVERY WIRE, BUT THE TIP OF THE DELIVERY WIRE AND THE SUBJECT COIL GOT STUCK IN THE MICROCATHETER. THE SUBJECT COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER TO THE OUTSIDE OF THE BODY. THE SAME MICROCATHETER WAS USED WITH THE NEW COIL TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11668634 ↗
• InjuryMar 17, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN USED A MICRO CATHETER TO DELIVER AND DEPLOY THE SUBJECT COIL AS A SECOND COIL INTO THE ANEURYSM IN MCA. WHILE THE PHYSICIAN WAS READJUSTING THE SUBJECT COIL IN AN ATTEMPT TO HAVE IT BETTER CONFIRM TO THE ANEURYSM WALL, IT PREMATURELY DETACHED PARTIALLY INSIDE THE ANEURYSM AND PARTIALLY IN THE PARENT VESSEL. A STENT WAS USED AS A SNARE/ADDITIONAL DEVICE TO TACK UP THE TAIL OF THE SUBJECT COIL WHICH WAS IN THE PARENT VESSEL. IT WAS REPORTED THAT THIS ATTEMPT SHUT DOWN THE MCA VESSEL AND THE PROCEDURE WAS COMPLETED WITHOUT TREATING THE OCCLUDED MCA. A FOLLOW-UP CT (COMPUTED TOMOGRAPHY SCAN) WAS CONDUCTED POST PROCEDURE AND IT WAS REPORTED THAT THE OCCLUSION APPEARED TO BE OPEN AND WAS NO LONGER OCCLUDED. IT WAS REPORTED THAT THE PATIENT IS SUFFERING FROM OTHER CO-MORBIDITIES UNRELATED TO THE PROCEDURE AND SUBJECT DEVICE. ACCORDING TO PHYSICIAN, PATIENT IS DOING WELL. NO OTHER CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11507120 ↗
• MalfunctionJul 9, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL PREMATURELY DETACHED IN THE HUB OF THE MICROCATHETER, INSIDE THE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8773266 ↗
• MalfunctionApr 10, 2019Migration; Migration

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO IMPLANT THE FIRST COIL WITHOUT ANY ISSUE. THE PHYSICIAN THEN IMPLANTED THE SECOND COIL (SUBJECT DEVICE); HOWEVER, GOT TANGLED WITH THE FIRST COIL. BOTH COILS WERE REMOVED AND REPLACED. NO KNOWN PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500304 ↗
• MalfunctionJul 6, 2018Break; Break

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, RESISTANCE WAS FELT WHILE INSERTING THE COIL DELIVERY WIRE IN THE HUB. THE COIL CAME BACK ROLLING IN THE HUB AND MAIN COIL WAS FOUND BROKEN. THE PROCEDURE WAS CONTINUED WITH NEW COIL. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7668057 ↗
• MalfunctionJun 12, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THAT WHEN THE COIL WAS ADVANCED IN THE MICROCATHETER, THE COIL DETACHED PREMATURELY INSIDE THE MICROCATHETER. THE COIL WAS RETRIEVED ALONG WITH THE MICROCATHETER. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7594795 ↗
• MalfunctionMay 25, 2018Break; Break

  ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE MAIN COIL WAS BROKEN. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7546179 ↗
• MalfunctionNov 17, 2017Premature Activation; Premature Activation

  ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE COIL WAS DETACHED FROM THE DELIVERY WIRE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7043455 ↗
• InjuryOct 9, 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 UN-RUPTURED ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY-POSTERIOR COMMUNICATING ARTERY. ON THE DAY OF THE PROCEDURE, THE PATIENT EXPERIENCED A FIRST HEADACHE. THE FIRST HEADACHE WAS RESOLVED THE NEXT DAY WITH NO RESIDUAL EFFECTS. TWO DAYS POST-PROCEDURE, THE PATIENT EXPERIENCED A SECOND HEADACHE. THE SECOND HEADACHE WAS ONGOING. MEDICATION WAS ADMINISTERED TO TREAT THE HEADACHE (2MG DEXAMETHASONE AND 1 MG MORPHINE AND 650 MG ACETAMINOPHEN). POST PROCEDURE, AT 2-MONTH, 6-MONTH, AND 12-MONTH POST-PROCEDURE THE PATIENT WAS NEUROLOGICALLY ASSESSED HAVING A MODIFIED RANKIN SCALE (MRS) OF 1. AT 2-MONTH, 6-MONTH, AND 12-MONTH POST-PROCEDURE THE PATIENT WAS ASSESSED HAVING A NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) OF 2. THE PHYSICIAN HAS INDICATED THAT THE 2 EVENTS OF HEADACHE WERE POSSIBLY RELATED TO THE INDEX PROCEDURE AND TO THE STENT AND NOT RELATED TO PRE-EXISTING CONDITION/CO-MORBIDITY. HOWEVER, IT IS UNKNOWN IF THE HEADACHE WAS RELATED TO THE IMPLANTED COILS (SUBJECT DEVICES) AND ACCESS DEVICES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Headache

  MAUDE report 6929577 ↗
• InjuryNov 2, 2016Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING STAGE II OF STENT-ASSISTED COIL EMBOLIZATION OF A GIANT PARTIALLY THROMBOSED ANTERIOR COMMUNICATING ARTERY (ACOMA) ANEURYSM, THE SUBJECT COIL KICKED OUT THE MICROCATHETER FROM THE ANEURYSM. THE COIL WAS PULLED BACK AND WHILE BEING RETRIEVED, BROKE WITH SOME OF THE COIL REMAINING IN THE ANEURYSM AND PROTRUDING HALFWAY INTO THE INTERNAL CAROTID ARTERY (ICA). ATTEMPTS TO REMOVE THE COIL RESULTED IN FURTHER STRETCHING OF THE COIL INTO THE ICA. FIRST ATTEMPT TO REMOVE THE COIL BY SNARE DEVICE WAS UNSUCCESSFUL AND THE DETACHED COIL ADVANCED INTO THE INTRACAVERNOUS SEGMENT OF THE ICA. THE COIL WAS EVENTUALLY REMOVED AFTER 2ND SNARE DEVICE TECHNIQUE WITH NO APPARENT COMPLICATIONS. PROCEDURE WAS CONSIDERED FINISHED AT THIS POINT WITH ONLY A SMALL SLIVER OF ANEURYSM NECK REMNANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6074094 ↗
• MalfunctionJul 29, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING PROCEDURE THE COIL STRETCHED AND DETACHED PREMATURELY. THE COIL WAS RETRIEVED. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5832718 ↗