TSX™ 00884450265598Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450265598), received between Nov 30, 2021 and Nov 30, 2021 — classified as 1 death.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A LEFT ATRIAL APPENDAGE CLOSURE [LAAC] PROCEDURE THE OPERATING PHYSICIAN EXPERIENCED COMPLICATIONS WITH A STEERABLE SHEATH. IT IS ALLEGED THAT "DEVICE ISSUES" MAY HAVE CAUSED OR CONTRIBUTED TO PATIENT COMPLICATIONS DURING THE PROCEDURE. THE ACCOUNT ALLEGES THAT "THE ATTENDING PHYSICIAN NEEDED TO REPOSITION THE STEERABLE SHEATH REPEATEDLY THROUGHOUT THE PROCEDURE". THE PATIENT EXPERIENCED A POSSIBLE "LEAK" [PERICARDIAL EFFUSION] THAT MAY HAVE LED TO POSSIBLE CARDIAC TAMPONADE ON THE LEFT ATRIAL APPENDAGE SIDE. A CODE WAS ACTIVATED, AND HOSPITAL PROTOCOLS WERE INITIATED IN ATTEMPTS TO STABILIZE THE PATIENT. THE LAA CLOSURE DEVICE WAS SUCCESSFULLY DEPLOYED DURING THIS PROCEDURE. THE PATIENT EXPIRED ON (B)(6) 2021. NO ADDITIONAL INFORMATION ABOUT THIS EVENT HAS BEEN PROVIDED TO MERIT MEDICAL BY THE ACCOUNT. A GOOD FAITH EFFORT OF 3 OR MORE ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN SUCCESSFULLY COMPLETED BY THE MANUFACTURER IN A TIMELY MANNER.

  Patient problems: Cardiac Arrest; Cardiac Perforation; Cardiac Tamponade

  MAUDE report 12902228 ↗