N/A 006173PRecalls & reported problems

Summary

The FDA's MAUDE database contains 161 adverse event reports that list this exact device (DI 00801741011207), received between Apr 26, 2017 and Sep 11, 2026 — classified as 34 injuries, 127 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (58 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 161 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735894 ↗
• MalfunctionSep 10, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718384 ↗
• MalfunctionSep 10, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718382 ↗
• MalfunctionAug 28, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50506881 ↗
• InjuryAug 24, 2026Nonstandard Device; No Pacing

  It was reported that during use the introducer performed as expected and was not associated with the incident. The malfunction was traced to the temporary pacing lead. The pacemaker generator and extension cable were replaced and tested in various combinations; however, the issue remained unresolved. The problem was ultimately resolved after replacing the pacing lead inserted into the patient, after which normal function was restored. During the initial use of the defective pacing lead, the patient developed asystole. External pacing had to be initiated, and the patient required sedation with medication boluses. For these frail elderly patient, the resulting complication and increased complexity of treatment caused harm.

  Patient problems: Asystole

  MAUDE report 50408862 ↗
• MalfunctionAug 11, 2026Disconnection

  It was reported multiple issues with the temporary pacing balloon catheter. During use, the yellow pins became detached from the wires. The customer stated that this issue had occurred several times during the doctor's procedures and raised concerns regarding the reliability of the device during critical cardiac interventions. The customer further stated that the malfunction had the potential to compromise patient safety. No patient injury or death was reported. The customer requested recommendations and possible alternative products to help ensure uninterrupted patient care.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50208707 ↗
• MalfunctionAug 6, 2026Accessory Incompatible; Fitting Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50166663 ↗
• MalfunctionAug 3, 2026Fitting Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50110036 ↗
• MalfunctionJun 26, 2026Difficult to Advance

  IT WAS REPORTED THAT THE BARD MEDICAL TEMPORARY PACING ELECTRODE CATHETER REF 006173P, LOT GFJU1609. THE CATHETER COULD NOT BE INSERTED DOWN TWO DIFFERENT INTRODUCER SETS AND CHECKED THE INTRODUCER WITH A FRESH CATHETER WHICH PASSES WITHOUT ISSUE, SO WE BELIEVE THE ISSUE TO BE WITH THE PACING ELECTRODE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25644447 ↗
• MalfunctionMay 28, 2026Disconnection

  IT WAS REPORTED BY CUSTOMER THAT THE MATERIAL DID NOT HAVE THE RESISTANCE TO HOLD IT TOGETHER, THE SAFETY ADAPTOR WAS NOT HOLDING CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25323319 ↗
• MalfunctionFeb 27, 2026Failure to Capture

  IT WAS REPORTED THAT AFTER USE OF THE BALLOON TEMPERATURE PACING ELECTRODE THE PATIENT ONCE AGAIN HAD A SUFFICIENT INTRINSIC RHYTHM POST INTERVENTIONAL DEFECT. THE PACEMAKER WAS REPLACED IN THE RECOVERY ROOM. THERE WERE NO COMPLICATIONS. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 26FEB2026, STATED THAT NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475402 ↗
• MalfunctionJan 27, 2026No Pacing

  IT WAS REPORTED THAT DURING USE, AFTER POSITIONING THE TEMPORARY PACING ELECTRODE IN THE PATIENT, A SECURE STIMULATION WAS NOT POSSIBLE. AS PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 20JAN2025, STATED THAT NO PATIENT WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24195894 ↗
• MalfunctionDec 19, 2025Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT DURING USE THE BALLOON TEMPORARY PACING ELECTRODE COULD NOT BE INSERTED AT THE EXIT POINT OF THE PROTECTIVE COVER. THE DOCTOR STOOD AT THE INSTRUMENT TABLE, DRESSED IN STERILE CLOTHING, AND PREPARED TO INSERT AN EXTERNAL PACEMAKER. TO PREPARE, THE STERILE PROTECTIVE COVER WAS SLID OVER THE FLUSHING CATHETER. THE CATHETER COULD NOT BE INSERTED AT THE EXIT POINT OF THE PROTECTIVE COVER. THE RESISTANCE WAS TOO GREAT; THE CATHETER KINKED AND COULD NOT BE GUIDED THROUGH THE PROTECTIVE COVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854828 ↗
• MalfunctionOct 21, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT BEFORE USE, THE TEMPORARY PACING ELECTRODE CATHETER BALLOON WAS TESTED SHORTLY BEFORE PLACEMENT. BALLOON DID NOT OPEN DURING THE TEST. TWO OTHERS HAD THE SAME PROBLEM. PER FOLLOW UP INFORMATION RECEIVED ON 03NOV2025, CUSTOMER CONFIRMED THAT TWO OTHERS HAD THE SAME PROBLEM WAS ALSO THE SAME BATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347640 ↗
• MalfunctionOct 10, 2025Nonstandard Device; Insufficient Device Problem Information; Nonstandard Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH TEMPORARY PACING ELECTRODE IN THE ICU. HAVE NOT GOTTEN DETAILS YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23268593 ↗
• MalfunctionOct 1, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent

  IT WAS REPORTED THAT THEY PRE-INFLATED THE BALLOON AND IT DID INFLATE BUT WAS "CROOKED". THEY USED THE PRODUCT ON THE ON THE PATIENT AND THE BALLOON RUPTURED IN THE PATIENT. INQUIRED IF IT CAUSED HARM TO THE PATIENT AND SHE STATED IT DID NOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23190408 ↗
• MalfunctionOct 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THEY PRE-INFLATED THE BALLOON AND IT DID INFLATE BUT WAS "CROOKED". THEY USED THE PRODUCT ON THE ON THE PATIENT AND THE BALLOON RUPTURED IN THE PATIENT. INQUIRED IF IT CAUSED HARM TO THE PATIENT AND SHE STATED IT DID NOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23190374 ↗
• MalfunctionSep 12, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT ONE BOX OF TEMPORARY PACING ELECTRODE CATHETER CAME IN WITH BLUE SUBSTANCE ON IT. PER FOLLOW UP RESPONSE RECEIVED VIA EMAIL ON 25SEP2025. IT WAS REPORTED THAT NO PHYSICAL SAMPLE IS AVAILABLE, AND PHOTO SAMPLE WAS ALREADY SUBMITTED. LOT GFKT0859 WAS CONFIRMED AS THE AFFECTED LOT. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037068 ↗
• MalfunctionFeb 20, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE CATHETER WAS INFLATED PRIOR TO INSERTION. THE BALLOON APPEARED TO BE LEAKING AND WAS REPORTED AS DEFECTIVE AND NOT USED. AS HAD HAPPENED SEVERAL TIMES BEFORE, THE BALLOON DID NOT INFLATE DURING THE FIRST TEST PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424092 ↗
• MalfunctionFeb 20, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE CATHETER WAS INFLATED PRIOR TO INSERTION. THE BALLOON APPEARED TO BE LEAKING AND WAS REPORTED AS DEFECTIVE AND NOT USED. AS HAD HAPPENED SEVERAL TIMES BEFORE, THE BALLOON DID NOT INFLATE DURING THE FIRST TEST PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421155 ↗
• MalfunctionFeb 18, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE CATHETER BALLOON DID NOT OPEN BEFORE THE CUSTOMER WANTED TO USE, IT WAS TESTED AS USUAL BEFORE IT WAS INSERTED THROUGH THE AIRLOCK. THE SYRINGE WAS FILLED WITH THE SPECIFIED AMOUNT OF AIR AND WHEN TRIED TO FILL THE BALLOON, IT DID NOT OPEN (LOT#: GFJT1350 AND LOT#: GFJT1029).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405181 ↗
• MalfunctionFeb 12, 2025Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT BARD TEMPORARY PACING ELECTRODE CATHETER BALLOON TESTING FAILED. DEVICE DID NOT ENTER PATIENT BODY, TESTED PRIOR TO USE. PER CUSTOMER FOLLOW UP ON 10MAR2025, IT WAS REPORTED THAT THERE WAS NO MORE INFORMATION AS FAR AS THE INCIDENT BUT NO HARM TO PATIENT AT ALL. THE MODEL # 006173P AND LOT # GFHQ1510.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363687 ↗
• MalfunctionDec 24, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THEY HAVE BEEN HAVING A LOT OF ISSUES WITH THE BALLOON NOT INFLATING ON THEIR BARD TEMPORARY PACING ELECTRODE CATHETERS. THEY WOULD SAY THEY HAD AT LEAST 14 FAULTY CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21011077 ↗
• MalfunctionDec 20, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT TEMPORARY PACING ELECTRODE CATHETER BALLOON WAS TESTED BEFORE USE, TO ENSURE NO AIR LEAKAGE WHEN IN USE, AND THE BALLOON DID NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20986664 ↗
• MalfunctionDec 12, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE CATHETER BALLOON WAS DEFECTIVE. THE BALLOON WAS TESTED BEFORE USE, AND DID NOT INFLATE. THE PRODUCT WAS THEREFORE NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913644 ↗