N/A 006172PRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741011191), received between Oct 29, 2019 and Apr 9, 2025 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2025Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT IT WAS ALREADY POINTED OUT TO IN A PREVIOUS EMAIL THAT YES, THE PATIENT HAS SUFFERED HARM AND WAS NOT THE ONLY ONE. THE PROBLEM HAD PERSISTED SINCE LAST YEAR. A REPORT HAD ALREADY BEEN MADE TO THE PHARMACY DEPARTMENT AND HAD REMOVED THE DEFECTIVE YELLOW CONNECTORS FROM OUR SERVICE SO THAT IT WOULD NO LONGER HAVE THIS PROBLEM. THE PREJUDICE WAS THAT IN THE EVENT OF AN EMERGENCY NEED FOR CARDIAC STIMULATION, THE CURRENT ASSEMBLY WITH DEFECTIVE YELLOW CONNECTORS DID NOT ALLOW THE STIMULATION TO BE DELIVERED. AS POINTED OUT TO IN A PREVIOUS EMAIL, THE CUSTOMER CANNOT PROVIDE WITH A BATCH NUMBER, BECAUSE THESE ELECTRODES WERE REUSED SEVERAL TIMES. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 01APR2025, STATED THAT THE TRACKING INFORMATION WOULD BE PROVIDED WHEN THE SAMPLE WILL BE READY FOR THE SHIPMENT, THE BATCH OF MATERIAL SENT CANNOT BE SUPPLIED TO YOU, AS IT WAS ALREADY REUSED ELECTRODES; AT THE TIME OF THE INCIDENT, THE PATIENT DID NOT SUFFER ANY PHYSICAL INJURY, BUT THE TREATMENT TOOK LONGER AND WAS THERE FOR FEW SECONDS WITHOUT A CARDIAC STIMULUS TILL THE TIME IT TOOK TO FIND OTHER ELECTRODES KEPT IN THE ROOM AND CHANGE THEM AND THE EVENT THAT TRIGGERED THIS

  Patient problems: Insufficient Information

  MAUDE report 21806407 ↗
• MalfunctionApr 8, 2025Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE HAD COMPATIBILITY PROBLEM WITH THE XTREM CONNECTION CABLE. THE PROBLEM WAS THAT THE YELLOW CONNECTORS FOUND IN BD TRAINING LEADS NO LONGER FIT ON XTREM STEERABLE LEAD CABLES. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 21MAR2025, IT WAS REPORTED THAT THE PATIENT HAS SUFFERED HARM AND WAS NOT THE ONLY ONE. THE PROBLEM HAD PERSISTED SINCE LAST YEAR. A REPORT HAD ALREADY BEEN MADE TO THE PHARMACY DEPARTMENT AND HAD REMOVED THE DEFECTIVE YELLOW CONNECTORS FROM OUR SERVICE SO THAT IT WOULD NO LONGER HAVE THIS PROBLEM. THE PREJUDICE WAS THAT IN THE EVENT OF AN EMERGENCY NEED FOR CARDIAC STIMULATION, THE CURRENT ASSEMBLY WITH DEFECTIVE YELLOW CONNECTORS DID NOT ALLOW THE STIMULATION TO BE DELIVERED. AS POINTED OUT TO IN A PREVIOUS EMAIL, THE CUSTOMER CANNOT PROVIDE WITH A BATCH NUMBER, BECAUSE THESE ELECTRODES WERE REUSED SEVERAL TIMES. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 27MAR2025, STATED THAT THE CUSTOMER CANNOT PROVIDE YOU WITH A BATCH NUMBER, AS THESE ELECTRODES ARE REUSED SEVERAL TIMES AND THESE ARE MATERIALS THAT HAVE NOT BEEN SOILED, AND THIS MATERIAL HAS ALREADY BEEN USED AT LEAST ONCE. THE SAMPLES ARE NOT CONTAMINATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21796915 ↗
• MalfunctionOct 30, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE FAULTY TEMPORARY PACING ELECTRODE. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 28OCT2024, STATED THAT THE 2 YELLOW AND BLACK BITS IN THE TEMPORARY PACING ELECTRODE SHOULD NOT BE LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20567155 ↗
• MalfunctionOct 30, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT BEFORE USE THE TEMPORARY PACING ELECTRODE CATHETER WAS FOUND FAULTY DURING A VERY SENSITIVE HEART VALVE IMPLANT CASE. THE YELLOW BIT SHOULD BE SEALED TO THE BLACK BIT, BUT THE TECH FINDS OUT DURING THE PROCEDURE IT WAS LOOSE AND LUCKILY IT DID HAPPEN JUST BEFORE DEPLOYING THE HEART VALVE INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566682 ↗
• MalfunctionOct 25, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE WHILE USING THE TEMPORARY PACING ELECTRODE PRODUCT 006172P, TEMPORARY PACING LEAD BALLOON FLOATATION BIPOLAR TEMP WIRE. THEY SPOTTED THAT THE COVER OF THE ELECTRODE AND THE SLEEVE FOR THE WIRE DID NOT MEET, THERE WAS A GAP IN THE INSULATION. SO, THE DEVICE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532966 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN THE ONLINE SURVEY A PHYSICIAN STATED THAT THE PATIENT EXPERIENCED PERFORATION (ARTERIAL OR CARDIAC), PERICARDIAL EFFUSION, TAMPONADE, INFECTION, SEPSIS PRIOR TO THE DEVICE PLACEMENT AND PERICARDIAL EFFUSION, BLEEDING, BACTERIAL INFECTION IN THE GROIN, SEPSIS COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE AND FEVER WAS NEEDED FOR INFECTION, AND SURGERY WAS NEEDED FOR SEPSIS, AND CABG WAS NEEDED FOR PERICARDIAL EFFUSION, AND ANEMIA LED TO TRANSFUSION WAS NEEDED FOR BLEEDING IN RELATION TO TEMPORARY PACING ELECTRODE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Sepsis

  MAUDE report 17660867 ↗
• MalfunctionJan 19, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE CATHETER SHAFT APPEARS WRINKLED INSIDE THE BLISTER. BEFORE OPENING THE BLISTER, NURSE NOTICED UNUSUAL WRINKLED SHAFT IN THE CATHETER. ALSO STATED 2 ITEMS OF THE SAME REFERENCE AND LOT IN THE SAME SITUATION AND THEY WERE NOT USED. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON (B)(6)2023, STATED THAT IN THE BLISTER, IT WAS NORMAL FOR THE CATHETER TO BE ROLLED UP IN 2 CIRCLES, BUT NOT FOR THE IT TO BE WRINKLED. IN THE PHOTO SAMPLE, THE OUTER CIRCLE OF THE CATHETER IT MAKES SOME "S'S", WHICH SHOULD NOT BE THERE. ALSO STATED THAT WAS NOT USUAL IN A CATHETER THAT HAS JUST BEEN OPENED AND NOT MANIPULATED. IT WAS NORMAL FOR IT TO BE STRAIGHT, JUST LIKE THE INNER CIRCLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16206589 ↗
• InjuryFeb 13, 2020Nonstandard Device; Product Quality Problem; Material Too Rigid or Stiff; Nonstandard Device

  IT WAS REPORTED THAT A MINIMUM OF 5 TIMES SINCE THE END OF 2017, PROVIDERS WHO HAD BEEN USING THE DEVICE HAD INSTANCES OF THE TIP OF THE CATHETER PUNCTURING THE WALL OF THE HEART, WHICH CAUSED CASES OF PERICARDIAL EFFUSION. IN NONE OF THE INSTANCES STAFF KEPT THE PACKAGING OR ANY PIECE OF THE CARDIAC CATHETER KIT. PROVIDERS REQUESTED A NEW TYPE OF CATHETER DEVICE, AND WHEN THEY BEGAN TO USE IT, THE PROBLEM SUBSIDED. THE NEW CATHETER KITS THEY USED EVENTUALLY RAN OUT OF STOCK, WHICH CAUSED THEM TO GO BACK TO AND USE THE ORIGINAL ONES, AND THIS CAUSED PROBLEMS FOR PATIENTS. AT THE END OF 2019, AFTER SWITCHING BACK TO THE BARD MEDICAL CATHETERS, A PROVIDER HAD ANOTHER PROBLEM WITH THE DEVICE. THE CARDIAC CATHETER LAB STAFF WERE ATTEMPTING TO PLACE THE DEVICE DURING A CARDIAC PROCEDURE IN (B)(6) FOR AN (B)(6) FEMALE. PER ADDITIONAL INFORMATION RECEIVED 24JAN2020 FROM THE COMPLAINANT, THE END OF THE CATHETER WAS ALLEGED TO BE TO HARD/RIGID, WHICH CAUSED THE TIP OF THE CATHETER TO PUNCTURE THE INNER WALLS OF THE HEART.

  Patient problems: Internal Organ Perforation; Perforation; Pericardial Effusion

  MAUDE report 9706799 ↗
• MalfunctionJan 16, 2020Defective Device

  AT A MINIMUM OF 5 TIMES SINCE THE END OF 2017, PROVIDERS WHO HAVE BEEN USING THE "BARD MEDICAL TEMPORARY PACING ELECTRODE CATHETER" HAVE HAD INSTANCES OF THE TIP OF THE CATHETER PUNCTURING THE WALL OF THE HEART, CAUSING CASES OF PERICARDIAL EFFUSION. IN NONE OF THESE INSTANCES DID STAFF KEEP ANY OF THE PACKAGING OR ANY PIECE OF THE CARDIAC CATHETER KIT. PROVIDERS REQUESTED A NEW TYPE OF CATHETER DEVICE, AND WHEN THEY BEGAN USING IT, THE PROBLEMS SUBSIDED. THE NEW CATHETER KITS THAT THEY WERE USING EVENTUALLY RAN OUT OF STOCK, CAUSING THEM TO GO BACK AND USE THE ORIGINAL ONES THAT WERE ORIGINALLY CAUSING PROBLEMS FOR PATIENTS. AT THE END OF 2019, AFTER SWITCHING BACK TO THE BARD MEDICAL CATHETERS, A PROVIDER HAD ANOTHER PROBLEM WITH A "BARD MEDICAL TEMPORARY PACING ELECTRODE CATHETER."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9595638 ↗
• MalfunctionOct 29, 2019Inflation Problem; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BALLOON ON THE ELECTRODE CATHETER WOULD NOT STAY INFLATED.

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

  MAUDE report 9252104 ↗