N/A 520007PRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00801741011535), received between Nov 17, 2017 and May 20, 2026 — classified as 3 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (14 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE CATHETER HAS A HAIR INSIDE THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234664 ↗
• MalfunctionMay 10, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CUSTOMER HAD A TEMPORARY PACING ELECTRODE CATHETER, THAT CONTAINED A HAIR INSIDE THE PACKAGING. A REQUEST WAS MADE FOR A REPLACEMENT TO BE SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25133596 ↗
• InjuryJul 10, 2025Adverse 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 AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO THE DEVICE "5F 110CM BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER, RIGHT HEART CURVE" WITH PRODUCT CODE 520007P, AND THE PATIENT EXPERIENCED "INFECTION" LOCATED IN "LUNG", AND IT DID NOT RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Unspecified Infection

  MAUDE report 22473410 ↗
• MalfunctionApr 9, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT BEFORE USE, THE TEMPORARY PACING ELECTRODE CATHETER BALLOON NOT INFLATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21806428 ↗
• MalfunctionApr 3, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DID NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762319 ↗
• MalfunctionApr 3, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT TEMPORARY PACING ELECTRODE CATHETER BALLOON INFLATION NOT SUSTAINED. MATERIAL DAMAGED DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761541 ↗
• MalfunctionApr 1, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE CRITICAL CARE NURSE REPORTED THAT IN THE ONLINE SURVEY THE ELECTRODE WAS NOT SUCCESSFULLY PLACED BECAUSE LEAD DISPLACEMENT IN RELATION TO THE DEVICE 5F 110CM BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER, RIGHT HEART CURVE WITH PRODUCT CODE OF TEMPORARY PACING ELECTRODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739585 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CRITICAL CARE NURSE REPORTED THAT IN THE ONLINE SURVEY A PHYSICIAN STATED THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO THE DEVICE 5F 110CM BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER, RIGHT HEART CURVE, AND THE PATIENT EXPERIENCED INFECTION LOCATED IN PUNCTURE SITE, AND IT DID NOT RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Unspecified Infection

  MAUDE report 21739571 ↗
• MalfunctionMar 27, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT IN THE ONLINE SURVEY A PHYSICIAN STATED THAT THE ELECTRODE WAS NOT SUCCESSFULLY PLACED BECAUSE LEAD DISPLACEMENT IN RELATION TO THE DEVICE 5F 110CM BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER, RIGHT HEART CURVE WITH PRODUCT CODE 520007P.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707290 ↗
• MalfunctionMar 17, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THEY ATTEMPTED TO USE THE BARD REF 520007P TEMPORARY PACING ELECTRODE CATHETER YESTERDAY AND THEY COULD NOT GET THE BALLOON TO INFLATE. THAT OCCURRED ON 2 SEPARATE TEMP PACERS. LOT GFJU0150. THEY HAD ANY ISSUES WITH THAT LOT? THEY WENT AHEAD AND PULLED ALL THAT THEY WITH THAT LOT. THEY HAD TOTAL OF 5. THEY ALSO HAD THEM KEPT ONE OF THE DEFECTIVE ONES WHICH THEY HAD IN THEIR OFFICE. LET THEM KNOW HOW THEY WANT TO PROCEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617975 ↗
• MalfunctionFeb 14, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE CATHETER BALLOON WOULD NOT INFLATE BEFORE CASE STARTED. NO IMPACT TO PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21383898 ↗
• MalfunctionJan 6, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE CATHETER WAS DEFECTIVE, A TEMPORARY PACING WIRE. THE BALLOON WAS NOT INFLATING PROPERLY. IT WAS REPORTED THAT CUSTOMER HAD ANOTHER DEFECTIVE TEMPORARY PACING ELECTRODE WIRE. THE BALLOON WOULD NOT INFLATE. THEY STILL HAD NOT RECEIVED THE PACKAGE TO RETURN THE DEFECTIVE BALLOON FROM (B)(6) 2024. THIS IS THE 3RD ONE THEY HAD AN ISSUE WITH IN THE PAST FEW MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079949 ↗
• MalfunctionNov 22, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE CATHETER WHEN ATTEMPTED TO USE, BALLOON WOULD NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20763858 ↗
• MalfunctionOct 24, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE CATHETER WAS DEFECTIVE, A TEMPORARY PACING WIRE. THE BALLOON WAS NOT INFLATING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523989 ↗
• MalfunctionAug 5, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUSTOMER HAD A COMPLAINT ON A CATHETER. PER FOLLOW UP VIA PHONE ON 16JUL2024, IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE BALLOON WAS FAULTY AND WOULD NOT BLOW UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905904 ↗
• MalfunctionJun 25, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE PROPERLY AND THERE WAS NO VISIBLE INFLATION. IT WAS TESTED BEFORE THE PROCEDURE THEREFORE NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604981 ↗
• MalfunctionMay 13, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT THE BALLOON TIP OF TEMPORARY PACING ELECTRODE LEAD WAS DEFECTIVE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19296602 ↗
• MalfunctionMar 13, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT 3 OUT OF 5 TEMPORARY PACING ELECTRODE CATHETERS WERE DEFECTIVE. ONCE INSERTED, THE BALLOONS WILL NOT INFLATE. LOT NUMBER WAS GFHU0871. CUSTOMER HAD BALLOONS FOR SAMPLES IF NEEDED. THEY ONLY HAD ONE OF THE BALLOONS KEPT AFTER USE. THEY WERE NOT POSITIVE OF THE LOT NUMBER OF THE OTHER 2 BUT WOULD LIKE TO ASSUME THEY WERE THE SAME LOT, SINCE THEY HAD THEM ALL OUT. BUT THEY CANNOT CONFIRM. THEY HAD THE ONE FROM TUESDAY LOT # GFHU0871 AND THEY HAVE ONE MORE OF THAT LOT UNOPENED. THEY ORDERED AND RECEIVED A NEW BOX WITH A DIFFERENT LOT # AND PUT THOSE OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18893637 ↗
• MalfunctionMar 13, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT 3 OUT OF 5 TEMPORARY PACING ELECTRODE CATHETERS WERE DEFECTIVE. ONCE INSERTED, THE BALLOONS WILL NOT INFLATE. LOT NUMBER WAS GFHU0871. CUSTOMER HAD BALLOONS FOR SAMPLES IF NEEDED. THEY ONLY HAD ONE OF THE BALLOONS KEPT AFTER USE. THEY WERE NOT POSITIVE OF THE LOT NUMBER OF THE OTHER 2, BUT WOULD LIKE TO ASSUME THEY WERE THE SAME LOT, SINCE THEY HAD THEM ALL OUT. BUT THEY CANNOT CONFIRM. THEY HAD THE ONE FROM TUESDAY LOT # GFHU0871 AND THEY HAVE ONE MORE OF THAT LOT UNOPENED. THEY ORDERED AND RECEIVED A NEW BOX WITH A DIFFERENT LOT # AND PUT THOSE OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18893512 ↗
• MalfunctionMar 7, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT DEFECTIVE TEMPORARY PACING ELECTRODE CATHETER BALLOON. INFLATED THE BALLOON PRIOR TO THE PROCEDURE AND THE BALLOON WOULD NOT HOLD ITS INFLATION. PRODUCT NEVER WENT INTO A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18856053 ↗
• MalfunctionJan 18, 2024Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE BALLOON IN THE TEMPORARY PACING ELECTRODE CATHETER WOULD NOT STAY INFLATED. IT WAS STATED THAT THEY ALSO HAD ANOTHER ONE FROM (B)(6)2023, THAT WHEN INFLATING THE BALLOON IN THE BOWL OF HEP SALINE PRIOR TO USE, THERE WAS A HOLE IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535382 ↗
• MalfunctionDec 13, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON IN THE TEMPORARY PACING ELECTRODE CATHETER WOULD NOT STAY INFLATED (LOT #GFHS0300). CUSTOMER ALSO HAD ANOTHER ONE FROM (B)(6) 2023, THAT WHEN INFLATING THE BALLOON IN THE BOWL OF HEP SALINE PRIOR TO USE, THERE WAS A HOLE IN THE BALLOON (LOT #GFHV2710).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18322090 ↗
• MalfunctionSep 21, 2023Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THE CUSTOMER HAD A TEMPORARY PACING ELECTRODES. ON (B)(6) 2023, THE BALLOON WOULD NOT STAY INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17789117 ↗
• MalfunctionJan 31, 2023Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE PERMANENT PACEMAKER OPERATION ON (B)(6) 2023 AND TEMPORARY PACING ELECTRODE CATHETER WAS USED FOR THE PROCEDURE. HOWEVER, THE 5FR CATHETER WAS NOT ABLE TO PASS THROUGH THE 5FR SHEATH DURING THE PROCEDURE. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 19JAN2023, THERE IS NO PATIENT INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16271578 ↗
• MalfunctionJul 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE TEMPERATURE PACING ELECTRODE BALLOON WAS NOT WORKING AND MUST BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112526 ↗