NBIH™ Temporary Pacing Electrode Catheter 007406PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741011368), received between Mar 1, 2023 and Mar 2, 2023 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT FOLLOWING TRANSCATHETER IMPLANTATION OF AN AORTIC VALVE, THE PATIENT EXPERIENCED AN ATRIOVENTRICULAR BLOCK, AND A TEMPORARY PACING ELECTRODE (TPE) CATHETER WAS PLACED. THE TPE CATHETER USED WAS A LARGER CALIBER THAN USUAL (CONTEXT OF LABORATORY RUPTURE). A 7F WAS USED INSTEAD OF THE USUAL 5F, BUT THE PATIENT WAS OKAY AT THE TIME OF DISCHARGE FROM THE BLOCK. THERE WAS TAMPONADE AT DAY 1 FOLLOWING THE TRANSCATHETER IMPLANTATION OF THE AORTIC VALVE WITH PRESENCE OF A FIBRILLATION ARTIALE DROITE (AF D; RIGHT-SIDED ATRIAL FIBRILLATION) BREACH. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM 3 HOURS LATER FOR THE REMOVAL OF THE PROBE AND TREATMENT. THERE WAS AN UNFAVORABLE SITUATION ON (B)(6) 2022 AT 7 PM, AND THE PATIENT EXPIRED. IT WAS REPORTED THAT A POTENTIAL CAUSE OF THE PATIENT¿S DEATH WAS RELATED TO THE STIMULATION PROBE. 7F STIMULATION PROBES ARE NO LONGER USED AT THIS FACILITY. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE INTERNATIONAL BUSINESS CENTERS (IBC) ON 03-FEB-2023, IT WAS REPORTED THAT THE DEVICE SEEMED VERY RIGID TO THE SURGEON. ADDITIONAL CLINICAL FOLLOW UP INFORMATION WAS RECEIVED VIA EMAIL ON 23-FEB-2023 FROM THE IBC. FOLLOWING THE T

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16466815 ↗
• DeathMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING TRANSCATHETER IMPLANTATION OF AN AORTIC VALVE, THE PATIENT EXPERIENCED AN ATRIOVENTRICULAR BLOCK, AND A TEMPORARY PACING ELECTRODE (TPE) CATHETER WAS PLACED. THE TPE CATHETER USED WAS A LARGER CALIBER THAN USUAL (CONTEXT OF LABORATORY RUPTURE). A 7F WAS USED INSTEAD OF THE USUAL 5F, BUT THE PATIENT WAS OKAY AT THE TIME OF DISCHARGE FROM THE BLOCK. THERE WAS TAMPONADE AT DAY 1 FOLLOWING THE TRANSCATHETER IMPLANTATION OF THE AORTIC VALVE WITH PRESENCE OF A FIBRILLATION ARTIALE DROITE (AF D; RIGHT-SIDED ATRIAL FIBRILLATION) BREACH. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM 3 HOURS LATER FOR THE REMOVAL OF THE PROBE AND TREATMENT. THERE WAS AN UNFAVORABLE SITUATION ON (B)(6) 2022 AT 7 PM, AND THE PATIENT EXPIRED. IT WAS REPORTED THAT A POTENTIAL CAUSE OF THE PATIENT¿S DEATH WAS RELATED TO THE STIMULATION PROBE. 7F STIMULATION PROBES ARE NO LONGER USED AT THIS FACILITY. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE INTERNATIONAL BUSINESS CENTERS (IBC) ON 03-FEB-2023, IT WAS REPORTED THAT THE DEVICE SEEMED VERY RIGID TO THE SURGEON. ADDITIONAL CLINICAL FOLLOW UP INFORMATION WAS RECEIVED VIA EMAIL ON 23-FEB-2023 FROM THE IBC. FOLLOWING THE T

  Patient problems: Atrial Fibrillation; Cardiac Tamponade

  MAUDE report 16459065 ↗