QDOT MICRO D139502Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835016727), received between Oct 18, 2023 and Oct 18, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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. How this data works · Data updated Oct 13, 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.

• InjuryOct 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH QDOT MICRO¿ CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT POST PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. THE PROCEDURE DATE WAS (B)(6) 2023 AND THE EFFUSION WAS DISCOVERED ON (B)(6) 2023. A PERICARDIOCENTESIS WAS PERFORMED IN WHICH 500 CCS WERE REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS STABLE AT THE TIME OF THE CALL. THE PATIENT FULLY RECOVERED AFTER PERICARDIOCENTESIS AND DID NOT REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. TRANSSEPTAL PUNCTURE WAS PERFORMED USING VERSACROSS RADIOFREQUENCY (RF) NEEDLE. THERE WAS NO EVIDENCE OF STEAM POP AND NO ERROR MESSAGES WERE OBSERVED ON THE BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 17959580 ↗