NA BIOD6DR252CT-TBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888551006477), received between Jul 27, 2021 and Jul 27, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K043513); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A FRAIL OLDER FEMALE PATIENT (PATIENT WEIGHT (B)(6)) WITH A MEDICAL HISTORY OF SUPRAVENTRICULAR TACHYCARDIA (SVT) UNDERWENT AN ELECTROPHYSIOLOGY STUDY PROCEDURE WITH TWO REPROCESSED EP DIAGNOSTIC CATHETERS WITH AUDIO ID DEFLECTABLE QUADRIPOLAR D CURVE AND EXPERIENCED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS. DURING THE STUDY PHASE, THE CATHETERS WERE PLACED, AND ONCE PROPRANOLOL WAS ADMINISTERED, HER HEART RATE INCREASED TO 140 AND THEN HER BLOOD PRESSURE DROPPED. THE DOCTOR COMPLETED AN INTRA-CARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING AND WAS ABLE TO DETECT THE LIQUID. AS A RESULT, THE PATIENT UNDERWENT A PERICARDIOCENTESIS. IT IS UNKNOWN HOW THE PATIENT DEVELOPED AN EFFUSION. THE PATIENT WAS MONITORED IN THE INTENSIVE CARE UNIT DUE TO HAVING A CATHETER IN HER PERICARDIUM. THE OUTCOME OF THE ADVERSE EVENT IS THAT THE PATIENT IS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE EVENT IS THAT IT WAS RELATED TO PATIENT CONDITION, SINCE THE PATIENT WAS FRAIL AND OLDER. NO ABLATION WAS PERFORMED PRIOR TO DISCOVERING THE CARDIAC TAMPONADE.

  Patient problems: Cardiac Tamponade

  MAUDE report 12226491 ↗
• InjuryJul 27, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A FRAIL OLDER FEMALE PATIENT (PATIENT WEIGHT 55KG) WITH A MEDICAL HISTORY OF SUPRAVENTRICULAR TACHYCARDIA (SVT) UNDERWENT AN ELECTROPHYSIOLOGY STUDY PROCEDURE WITH TWO REPROCESSED EP DIAGNOSTIC CATHETERS WITH AUDIO ID DEFLECTABLE QUADRIPOLAR D CURVE AND EXPERIENCED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS. DURING THE STUDY PHASE, THE CATHETERS WERE PLACED, AND ONCE PROPRANOLOL WAS ADMINISTERED, HER HEART RATE INCREASED TO 140 AND THEN HER BLOOD PRESSURE DROPPED. THE DOCTOR COMPLETED AN INTRA-CARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING AND WAS ABLE TO DETECT THE LIQUID. AS A RESULT, THE PATIENT UNDERWENT A PERICARDIOCENTESIS. IT IS UNKNOWN HOW THE PATIENT DEVELOPED AN EFFUSION. THE PATIENT WAS MONITORED IN THE INTENSIVE CARE UNIT DUE TO HAVING A CATHETER IN HER PERICARDIUM. THE OUTCOME OF THE ADVERSE EVENT IS THAT THE PATIENT IS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE EVENT IS THAT IT WAS RELATED TO PATIENT CONDITION, SINCE THE PATIENT WAS FRAIL AND OLDER. NO ABLATION WAS PERFORMED PRIOR TO DISCOVERING THE CARDIAC TAMPONADE.

  Patient problems: Cardiac Tamponade

  MAUDE report 12226471 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043513. One submission often covers many models, so check the product and lot details in each record.

• Z-0555-2009 · Aug 8, 2008 · Terminated
  EP Catheter Model #'s: BIOD6-DR-005-RT BIOD6-DR-010-RT DAI401381 DAI401449 DAI401904 DAI401915 and EPT7003D Intended for temporary use during electrophysiology studies for intrac