TSX™ 00884450466629Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450466629), received between Oct 19, 2021 and Nov 3, 2022 — classified as 3 injuries.

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.

• InjuryNov 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT THE PHYSICIAN WAS ATTEMPTING TO ACQUIRE ACCESS TO THE LEFT ATRIUM VIA TRANSEPTAL PUNCTURE AFTER MAPPING THE RIGHT ATRIUM. THE PERICARDIUM HAD BEEN PUNCTURED. THE PATIENT WAS TAKEN OFF THE TABLE AND TRANSFERRED TO ICU FOR FURTHER OBSERVATION AND EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15723313 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER ALLEGES THAT DURING A TRANSSEPTAL PUNCTURE FOR PATIENT NEEDING A LEFT ATRIAL APPENDAGE CLOSURE DEVICE DEPLOYED. WHEN THE PHYSICIAN WAS REMOVING THE SHEATH, TWO PERFORATIONS AND INTERNAL BLEEDING WAS NOTED WITHIN THE PATIENT'S HEART. THE PATIENT EXPERIENCED PERICARDIAL EFFUSION, CARDIAC TAMPONADE AND AN EMERGENT PERICARDIOCENTESIS. THE PATIENT WAS ADMITTED AND TRANSFERRED TO SURGICAL UNIT FOR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15434666 ↗
• InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING THE TRANSSEPTAL PUNCTURE, THE PHYSICIAN OBSERVED A SMALL PERICARDIAL EFFUSION AFTER MULTIPLE ATTEMPTS TO MAKE THE TRANSSEPTAL CROSS. UPON REVIEW OF THE TEE, AND TO ENSURE PATIENT SAFETY, THE PHYSICIAN CANCELLED THE PROCEDURE AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR CLOSE MONITORING. THE PATIENT IS STABLE AND IN GOOD CONDITION.

  Patient problems: Pericardial Effusion

  MAUDE report 12657532 ↗