TARGET M0035467200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540676306), received between Jan 17, 2022 and Feb 13, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING RIGHT INTERNAL CAROTID ARTERY (ICA) C5 ANEURYSM PROCEDURE, THE OPERATOR USED THE GUIDEWIRE TO BRING THE MICROCATHETER TO THE ANEURYSM. NEXT, THE OPERATOR FRAMED THE ANEURYSM WITH THE SUBJECT COIL AND INSERTED THE SUBJECT COIL TO GO INTO THE ANEURYSM. HOWEVER, THE OPERATOR DID NOT CONTROL THE TENSION AND THE MICROCATHETER WENT INTO THE PARENT VESSEL. THE OPERATOR TRIED TO RETRACT THE SUBJECT COIL TO DELIVER AGAIN BUT DURING THE RETRACTION INTO THE INTRODUCER SHEATH THE SUBJECT COIL FRACTURED AT THE DETACHMENT POINT. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18698067 ↗
• MalfunctionJul 21, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL DETACHED PREMATURELY INSIDE THE MICROCATHETER. THE PHYSICIAN PUSHED THE SUBJECT COIL INTO THE ANEURYSM AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15071825 ↗
• InjuryJan 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A CLINICAL TRIAL PROCEDURE TO TREAT A RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM, THE PATIENT HAD HEMIANOPIA AND DELIRIUM. ON IMAGING, OCCIPITAL MICRO EMBOLIC INFARCTS WERE SEEN WHICH RESULTED IN PROLONGED HOSPITALIZATION FOR THE PATIENT. THE EVENT WAS TREATED WITH PHYSIOTHERAPY AND ORAL OLANZAPIN 5 MG FOR DELIRIUM FOR 5 DAYS AND RECOVERED. IN THE PHYSICIAN'S OPINION, THE EVENT WAS POSSIBLY RELATED TO THE SUBJECT DEVICE AND OTHER STRYKER DEVICES USED IN THE PROCEDURE.

  Patient problems: Cognitive Changes; Visual Impairment

  MAUDE report 13272011 ↗