NBIH™ Temporary Pacing Electrode Catheter 007153PRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741011290), received between Jan 31, 2020 and Aug 7, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “No Pacing” (4 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Fitting Problem

  It was reported that the connector has become loose and is not functioning properly, which may affect the reliability and safe operation of the equipment.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50181853 ↗
• MalfunctionMay 27, 2025No Pacing; No Pacing

  IT WAS REPORTED THAT THE INTERVENTIONAL CARDIOLOGIST WAS NOT ABLE TO NAVIGATE THE TEMPORARY PACING ELECTRODE LEAD IN RIGHT VENTRICLE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087658 ↗
• MalfunctionApr 8, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT TEMPORARY PACING ELECTRODE CATHETER COULD NOT REACH AN OUTPUT OF MORE THAN 15 SO NO CHANGE IN THE WIRES WAS OBSERVED AND THE PROBLEM. IT WAS NOTED THAT THE GIVEN LOT# WAS GFFS2570.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21797385 ↗
• MalfunctionDec 11, 2024No Pacing; No Pacing

  IT WAS REPORTED THAT THE SURGEON SAID THAT THERE WAS NO CURRENT OUTPUT FROM THE TEMPORARY PACING ELECTRODE AFTER THE TEMPORARY PACEMAKER WAS CONNECTED, SO A NEW ONE WAS REPLACED, AND IT WORKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901848 ↗
• MalfunctionAug 13, 2024No Pacing; No Pacing

  IT WAS REPORTED THAT THERE WAS NO CURRENT OUTPUT AFTER CONNECTING THE TEMPORARY PACEMAKER, AND THEY CHANGED TO A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19975405 ↗
• MalfunctionAug 6, 2024Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT THERE HAD BEEN A BACK ORDER OF TEMPORARY PACER INSERTION KIT WITH 5 FR BALLOON TIP PACING WIRE OR CATHETER. MATERIALS REPLACED WITH THE ARGON SHEATH KIT (6 FR) AND A 6 FR PACING CATHETER OR WIRE, NOT A BALLOON TIP. FOR AN EMERGENCY BEDSIDE INSERTION ON PROGRESSIVE CARE UNIT, THE PHYSICIAN WENT TO INSERT THE CATHETER OR PACING WIRE, AND IT DID NOT HAVE A BALLOON TIP THAT ASSISTED WITH FLOATING, ADVANCING THE CATHETER INTO THE RIGHT VENTRICLE WHEN NOT IN THE CATHETER LAB UNDER FLURO. THE NON-BALLOON TIP CATHETERS WERE MORE DIFFICULT TO INSERT. THE CARDIAC SURGERY INTENSIVE CARE UNIT STAFF CAME TO ASSIST AND WERE UNAWARE THAT THESE REPLACEMENT ITEMS WERE BEING STOCKED. ALSO NOTED IN SOME OF THE UNITS THE TEMPORARY PACING CATHETERS WERE 6 FR, AND THIS WOULD NOT FIT THROUGH THE 6 FR SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918282 ↗
• MalfunctionAug 6, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THERE HAD BEEN A BACK ORDER OF TEMPORARY PACER INSERTION KIT WITH 5 FR BALLOON TIP PACING WIRE OR CATHETER. MATERIALS REPLACED WITH THE ARGON SHEATH KIT (6 FR) AND A 6 FR PACING CATHETER OR WIRE, NOT A BALLOON TIP. FOR AN EMERGENCY BEDSIDE INSERTION ON PROGRESSIVE CARE UNIT, THE PHYSICIAN WENT TO INSERT THE CATHETER OR PACING WIRE, AND IT DID NOT HAVE A BALLOON TIP THAT ASSISTED WITH FLOATING, ADVANCING THE CATHETER INTO THE RIGHT VENTRICLE WHEN NOT IN THE CATHETER LAB UNDER FLURO. THE NON-BALLOON TIP CATHETERS WERE MORE DIFFICULT TO INSERT. THE CARDIAC SURGERY INTENSIVE CARE UNIT STAFF CAME TO ASSIST AND WERE UNAWARE THAT THESE REPLACEMENT ITEMS WERE BEING STOCKED. ALSO NOTED IN SOME OF THE UNITS THE TEMPORARY PACING CATHETERS WERE 6 FR, AND THIS WOULD NOT FIT THROUGH THE 6 FR SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917040 ↗
• InjuryJun 24, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT CUSTOMER WAS NOT USED TO SEEING TEMPORARY PACING ELECTRODE CATHETERS WITHOUT A BALLOON TO FLOAT. THE ITEM PICTURED BELOW, 007153P WAS NOT A BALLOON PACING ELECTRODE. THEY DO OFFER BALLOON PACING ELECTRODES BUT NOT IN A 6FR. BELOW THEY HAVE LISTED THE TEMPORARY PACING CATHETERS AVAILABLE WITH A BALLOON. PCN INCLUDES PCN #006172P, PCN #006173P, PCN #520007P. BUT THE COMPLICATION WAS REPORTED IN PCN #007153P. CUSTOMER THEN STATED STAFF THOUGHT THAT PREVIOUSLY THEY HAD BALLOON TIPPED TVP ELECTRODES, BUT WHEN THEY LOOKED AT THE TVP YESTERDAY, THEY HAD NO BALLOON IN IT AND HAD A PERICARDIAL EFFUSION THOUGHT TO BE CAUSED BY THE TVP, BECAUSE OF WHICH IT HAS BEEN REPORTED TO QUALITY. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR PERICARDIAL EFFUSION.

  Patient problems: Pericardial Effusion

  MAUDE report 19594767 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BIPOLAR PACING ELECTRODE CATHETER WAS USED ON (B)(6) 2021 DURING EARLY CORONARY ANGIOGRAPHY (CAG) AND PERCUTANEOUS CORONARY INTERVENTION (PCI) AND THE PATIENT GOT CARDIAC TAMPONADE, WHICH WAS LIFE-THREATENING FOR THE PATIENT. THE PATIENT IMPROVED AFTER TRANS PERICARDIOCENTESIS AND DRAINED ON (B)(6) 2021.

  Patient problems: Cardiac Tamponade

  MAUDE report 15362937 ↗
• MalfunctionApr 1, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE BIPOLAR PACING ELECTRODE CATHETER PACKAGING WAS OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13981131 ↗
• MalfunctionMay 13, 2020No Pacing; No Device Output; No Pacing

  IT WAS REPORTED THAT THERE WAS NO CURRENT OUTPUT, WITH IMPEDANCE EXCEEDING 200. SHORT CIRCUIT WAS POSSIBLE SINCE THERE WERE NO ELECTRODES.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10051510 ↗
• MalfunctionJan 31, 2020Pacing Problem; Failure to Power Up; Pacing Problem

  IT WAS REPORTED THAT THE BIPOLAR PACING ELECTRODE CATHETER WOULD NOT POWER UP, AND THE HOSE WAS CHANGED BUT THE DEVICE STILL DID NOT WORK. ANOTHER PROBE WAS USED ON THE PATIENT TO COMPLETE THE PROCEDURE BUT THE PROCEDURE WAS DELAYED AND THE PATIENT WAS IN A DELICATE STATE. PER ADDITIONAL INFORMATION FROM THE IBC VIA EMAIL 09JAN2020, THE DEVICE WOULD NOT PRODUCE AN ELECTRICAL CURRENT OR PACE. THE PATIENT DID NOT REQUIRE ADDITIONAL SEDATIVES OR MEDICATION TO MAINTAIN CARDIAC OUTPUT WHILE THE ELECTRODES WERE SWITCHED OUT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9653526 ↗