QDOT MICRO D139403Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10846835017106), received between Nov 21, 2023 and Apr 24, 2025 — classified as 1 death, 1 injury, 4 malfunctions.

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

• MalfunctionApr 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ONE QDOT MICRO¿ CATHETER WAS RECEIVED BY THE BWI PRODUCT ANALYSIS LAB WITH NO ACCOMPANYING INFORMATION AND WAS PROCESSED. THE DEVICE COULD NOT BE ASSOCIATED WITH AN EXISTING COMPLAINT. IN THE ABSENCE OF CLARIFYING INFORMATION, IT CANNOT BE DETERMINED WHY THIS DEVICE WAS RETURNED TO BWI. HOWEVER, VISUAL ANALYSIS REVEALED THAT THERE WAS A HOLE IN THE PEBAX. AS A RESULT, THIS WILL BE REPORTED TO FDA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903532 ↗
• MalfunctionJan 24, 2025Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A HOLE IN THE PEBAX. DURING THE PROCEDURE, THE CATHETER FORCE VECTOR DISPLAYED INAPPROPRIATELY AND INVERTED DESPITE MULTIPLE ATTEMPTS TO ZERO THE CATHETER. NO ERRORS WERE DISPLAYED. THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21231106 ↗
• MalfunctionAug 14, 2024Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A QDOT MICRO FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT A MAP MAGNETIC DISTORTION ERROR DISPLAYED WHEN PHYSICIAN WOULD COME ON ABLATION AND THE CATHETER WOULD JUMP OUTSIDE OF THE FAM (ERROR NUMBER UNKNOWN BY CALLER). CALLER STATED THAT THEY SHIFTED AROUND THE PATIENT TABLE WITHOUT RESOLUTION. THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED. THE CUSTOMER'S REPORTED MAGNETIC SENSOR ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 18-JUL-2024, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A HOLE IN THE PEBAX AND A REDDISH MATERIAL INSIDE THE PEBAX. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF A ¿HOLE¿ IN THE PEBAX AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19984488 ↗
• InjuryJan 23, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND PATIENT EXPERIENCED CARDIAC TAMPONADE TREATED WITH A PERICARDIOCENTESIS. IT WAS REPORTED BY THE CALLER THAT A PERICARDIAL EFFUSION WAS DETECTED. DURING ABLATION PHASE, THE PHYSICIAN NOTICED THE HEART WAS NOT MOVING UNDER FLUOROSCOPY, CHECKED THE BLOOD PRESSURE, AND A 90/50 WAS IDENTIFIED. THE PHYSICIAN CONFIRMED IT BY USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE). MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS, ALSO 2 UNITS OF BLOOD, AND PLATELETS WERE PROVIDED. THE PATIENT OUTCOME IS FULLY RECOVERED AND DID NOT REQUIRE EXTENDED HOSPITALIZATION. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. THE PHYSICIAN STATED EITHER PERFORATION FROM DIFFICULTY ACCESSING CORONARY SINUS WITH ABLATION CATHETER OR POSSIBLE STACKED LESIONS ON POSTERIOR LEFT ATRIAL SEPTUM. CORRECT DEVICE SETTINGS SELECTED ON THE GENERATOR AND THERE WERE NO ERROR MESSAGES ON EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE PERFORMED WITH BAYLIS NRG CO NEEDLE AND ABLATION WAS PERFORMED. NO EVIDENCE OF STEAM POP.

  Patient problems: Cardiac Perforation

  MAUDE report 18565081 ↗
• MalfunctionJan 11, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THEY WERE UNABLE TO ZERO THE CATHETER. THE CALLER STATED THAT THE FORCE READING OF THE CATHETER WAS DISPLAYED ON THE CARTO 3 SYSTEM AS HI. THE CABLE WAS REPLACED WITH NO RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER'S REPORTED FORCE ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 20-DEC-2023, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A HOLE IN THE PEBAX AND A REDDISH MATERIAL INSIDE THE PEBAX. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF A ¿HOLE¿ IN THE PEBAX AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491845 ↗
• DeathNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE USING A QDOT CATHETER. THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA / FIBRILLATION DURING THE PROCEDURE BUT ULTIMATELY DIED IN RECOVERY. THE INITIAL CASE ON 26-OCT-2023 WENT PERFECTLY SMOOTHLY WITH NO REPORTABLE ISSUES. HOWEVER "IN THE MIDDLE OF THE NIGHT" WHEN A NURSE WAS CHECKING ON THE PATIENT THEY FOUND THE PATIENT HAD PASSED AWAY. THE ONLY DETAILS THE MEDICAL TEAM HAVE ABOUT THE DEATH SO FAR ARE THAT DURING THE CASE THEY WENT FROM VENTRICULAR TACHYCARDIA (VT) TO VENTRICULAR FIBRILLATION (VF) VERY QUICKLY. THE ABLATION CATHETER CANNOT BE EXCLUDED AS A CONTRIBUTING FACTOR TO THE PATIENT'S DEATH (AS THERE IS NO CAUSE OF DEATH REPORTED AND THE PROCEDURE WAS RIGHT BEFORE PATIENT'S DEATH) AND THUS THIS EVENT IS BEING REPORTED UNDER THE ABLATION CATHETER.

  Patient problems: Ventricular Fibrillation

  MAUDE report 18185392 ↗