TARGET M0035431540Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540698056), received between Nov 2, 2016 and Aug 8, 2023 — classified as 2 injuries, 4 malfunctions.

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

• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE LEFT MIDDLE CEREBRAL ARTERY M2 ANEURYSM CASE WHILE DELIVERY OF THE SUBJECT COIL, RESISTANCE WAS ENCOUNTERED IN THE MICROCATHETER. ON WITHDRAWAL OF THE SUBJECT COIL, THROMBUS WAS GENERATED IN THE MICROCATHETER. THE THROMBUS WAS ASPIRATED FROM MICROCATHETER. THE PHYSICIAN REPLACED THE SUBJECT COIL WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17480989 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE, WHEN THE SUBJECT COIL WAS CLOSE TO THE DISTAL TIP OF THE MICROCATHETER, IT WAS EVIDENT THAT THE SUBJECT COIL BEGAN TO TWIST, TAKING ITS HELICAL SHAPE INSIDE THE MICROCATHETER. THE SUBJECT COIL GOT STUCK AND DID NOT ADVANCE TO THE ANEURYSM. THE OPERATOR RETRACTED THE SUBJECT COIL AND THEN ADVANCED IT AGAIN BUT THE SUBJECT COIL GOT STUCK AGAIN AND DID NOT ADVANCE. THEREFORE HE DECIDED TO REMOVE THE SUBJECT COIL. A UNKNOWN MEDICAL INTERVENTION WAS REPORTED DUE TO THIS EVENT. SURGICAL DELAY OF 5 MINUETS WAS NOTED. IN ADDITION THE FILLING OF THE ANEURYSM COULD NOT BE FINISHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17339643 ↗
• MalfunctionJun 25, 2021Premature Separation; Premature Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12068468 ↗
• MalfunctionApr 8, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL WAS NOTED TO BE STRETCHED AND HAD PREMATURELY DETACHED DURING USE. THE PHYSICIAN REPLACED WITH ANOTHER OF THE SAME DEVICE AND COMPLETED THE PROCEDURE SUCCESSFULLY. THE PATIENT WAS STABLE AND NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SUBJECT COIL WAS NOT PREMATURELY DETACHED AS THE COIL WAS STILL INTACT THEREFORE, BASED ON THIS INFORMATION THE EVENT IS DEEMED NON-REPORTABLE AND EMDR REDACTION WILL BE FILED WITH AN AWARE DATE OF 27-JUL-2020. THE EVENT WILL BE RE-ASSESSED TO REFLECT THE DECISION CHANGE AND EMDR WILL BE FILED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9936343 ↗
• MalfunctionNov 2, 2016Break; Break

  IT WAS REPORTED THAT AFTER THE COIL WAS INTRODUCED INTO THE ANEURYSM, THE PHYSICIAN DECIDED TO RESHEATH THE COIL TO BE RE-INTRODUCED INTO THE MICROCATHETER. THE COIL BROKE OFF AT THE JUNCTION OF THE MICROCATHETER DURING RE-INTRODUCTION. THE PHYSICIAN CUT THE HUB OF THE MICROCATHETER TO RETRIEVE THE BROKEN COIL. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6074671 ↗
• MalfunctionNov 2, 2016Break; Break

  IT WAS REPORTED THAT AFTER THE COIL WAS INTRODUCED INTO THE ANEURYSM, THE PHYSICIAN DECIDED TO RESHEATH THE COIL TO BE RE-INTRODUCED INTO THE MICROCATHETER. THE COIL BROKE OFF AT THE JUNCTION OF THE MICROCATHETER DURING RE-INTRODUCTION. THE PHYSICIAN CUT THE HUB OF THE MICROCATHETER TO RETRIEVE THE BROKEN COIL. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6074651 ↗