TARGET M0035477200Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540676573), received between Oct 9, 2017 and Jan 22, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM CASE, OPERATOR TRIED TO ADJUST THE POSITION OF THE SUBJECT COIL WITHIN THE ANEURYSM THE SUBJECT COIL WAS NOT ABLE TO BE RETRACTED, NOR IT WAS MOVING. WHEN THE SUBJECT COIL WAS SLOWLY RETRIEVED IT WAS FOUND TO BE STRETCHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT. THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT MAIN COIL WAS PREMATURELY DETACHED /SEPARATED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21208607 ↗
• MalfunctionSep 8, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING LEFT POSTERIOR COMMUNICATING ARTERY (PCOMA) ANEURYSM PROCEDURE, THE OPERATOR PREPARED TO FILL THE SUBJECT COIL. HOWEVER, WHEN ADVANCING THE SUBJECT COIL INSIDE THE MICROCATHETER BIG RESISTANCE WAS ENCOUNTERED. THE OPERATOR WITHDREW THE SUBJECT COIL AND FOUND IT FRACTURED. 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 17712021 ↗
• MalfunctionJan 4, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE MEDICAL PROCEDURE, THE SUBJECT COIL WAS DIFFICULT TO ADVANCE THROUGH THE MICROCATHETER. A SLIGHT KINK WAS NOTICED ON THE SUBJECT COIL DELIVERY WIRE. PHYSICIAN CONTINUED TO ADVANCE THE SUBJECT COIL BUT WAS UNSUCCESSFUL. HE DECIDED TO REMOVE THE SUBJECT COIL AND WHEN IT WAS PULLED, THE SUBJECT COIL GOT DETACHED FROM THE PUSHER WIRE INSIDE THE CATHETER. THE SUBJECT COIL WAS REMOVED ALONG WITH THE CATHETER. 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 16095816 ↗
• MalfunctionAug 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE BASILAR ARTERY ANEURYSM PROCEDURE, THE SUBJECT COIL WAS BROKEN WHILE ADVANCING WITHIN THE MICROCATHETER PRIOR TO THE DEPLOYMENT. 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 15291337 ↗
• InjuryAug 7, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, WHILE DEPLOYING THE 5TH COIL, IT GOT STUCK AFTER A FEW MM INSIDE THE ANEURYSM. IT WAS IMPOSSIBLE TO PUSH IT INSIDE THE ANEURYSM OR PULL IT OUT, SO THE PHYSICIAN RETRIEVED A LITTLE BIT BACK AND SAW THE FIFTH COIL AND THE SUBJECT DETACHED COIL AT THE MICROCATHETER¿S TIP. THE PHYSICIAN PULLED THE MICROCATHETER BACK WHILE PUSHING THE COIL UNTIL IT GOT RELEASED AND THEN PULLED IT BACK. HOWEVER, THE TIP OF THE SUBJECT COIL WAS PROTRUDED OUT OF THE ANEURYSM AND REMAINED OUTSIDE. THERE WAS A STENT THAT PROTECTED, AND THE PHYSICIAN STOPPED WITH COILING SINCE HE LOST THE MICROCATHETER POSITION. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8872294 ↗
• MalfunctionJan 10, 2019Break; Break

  ANALYSIS OF THE DEVICE REVEALED THAT THE COIL WAS BROKEN.THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8237477 ↗
• InjuryOct 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE STENT ASSISTED COIL EMBOLIZATION PROCEDURE, THE PATIENT EXPERIENCED HEADACHE WHICH RESOLVED WITHOUT RESIDUAL EFFECT THE NEXT DAY. POST PROCEDURE THE PATIENT WAS ASSESSED HAVING A MRS OF 0. ALSO, THE ANEURYSM OCCLUSION STATUS POST PROCEDURE WAS ASSESSED AS COMPLETE OBLITERATION, NO OPACIFICATION OF THE ANEURYSM OR NECK, (LEAVING NECK TO PRESERVE BRANCH IS CONSIDERED MODIFIED CLASS I). THE STUDY FACILITY ASSESSED THE HEADACHE AS BEING POSSIBLY RELATED TO THE STENT AND PROCEDURE; HOWEVER, UNKNOWN TO THE IMPLANTED COILS (SUBJECT DEVICE) AND MICROCATHETERS. DURING FOLLOW UP VISITS AT 2, 6, AND 12 MONTHS POST THE INDEX PROCEDURE, THE PATIENT WAS ASSESSED HAVING A MRS OF 0. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Headache

  MAUDE report 6932985 ↗