N/A 006225PRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741011221), received between Dec 3, 2021 and May 11, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “No Pacing” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Missing Information

  IT WAS REPORTED THAT ON 05MAY2026, RECEIVED THE SUPPLIER BD WHICH FINISHED DOWNLOADING AT 20:40 APPROXIMATELY WHICH WAS NOT CARRIED OUT THE DETAILED REVIEW OF THE MATERIAL, COULD VALIDATE AND THE PRODUCT CODE 006225P, LOT GFKN0913 A PIECE BRINGS BROKEN BACK LABEL AND PHOTO SAMPLE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135700 ↗
• MalfunctionMar 27, 2025No Pacing; No Pacing

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED THAT IN THE ONLINE SURVEY A PHYSICIAN STATED THAT THE TEMPORARY PACING ELECTRODE WAS NOT SUCCESSFULLY ABLE TO CAPTURE AND PACE FOR THE CHOSEN DURATION OF USE BECAUSE NONE IN RELATION TO 5F 115CM SEMI-FLOATING TEMPORARY PACING ELECTRODE CATHETER, BIPOLAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21706668 ↗
• MalfunctionMar 26, 2025No Pacing; No Pacing

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE ELECTRODE WAS NOT SUCCESSFULLY ABLE TO CAPTURE AND PACE FOR THE CHOSEN DURATION OF USE" BECAUSE "NONE" IN RELATION TO THE DEVICE "5F 115CM SEMI-FLOATING TEMPORARY PACING ELECTRODE CATHETER, BIPOLAR" WITH PRODUCT CODE 006225P.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697897 ↗
• MalfunctionMar 26, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN THE ONLINE SURVEY THAT THE TEMPORARY PACING ELECTRODE WAS NOT SUCCESSFULLY PLACED BECAUSE EFFICACY IN RELATION TO 5F 115CM SEMI-FLOATING TEMPORARY PACING ELECTRODE CATHETER, BIPOLAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697620 ↗
• MalfunctionMar 26, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE ELECTRODE WAS NOT SUCCESSFULLY PLACED BECAUSE EFFICACY IN RELATION TO THE DEVICE "5F 115CM SEMI-FLOATING TEMPORARY PACING ELECTRODE CATHETER, BIPOLAR" WITH PRODUCT CODE 006225P.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697199 ↗
• MalfunctionJun 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT CRITICAL CARE PHYSICIAN IN THE ONLINE SURVEY STATED THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO THE TEMPORARY PACING ELECTRODE AND THE PATIENT EXPERIENCED ARRYTHMIA (VENTRICULAR TACHYCARDIA, VENTRICULAR FIBRILLATION), PERFORATION (ARTERIAL OR CARDIAC) AND PULMONARY EMBOLISM. THIS RESULTED IN THE PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 04JUN2024, PHYSICIAN ALSO INDICATED CATHETER DISPLACEMENT OCCURRED AFTER TEMPORARY PACING ELECTRODE CATHETER PLACEMENT. THE PHYSICIAN INDICATED THIS COMPLICATION TO BE A PROCEDURE RELATED COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593064 ↗
• InjuryMay 28, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CRITICAL CARE PHYSICIAN REPORTED IN THE ONLINE SURVEY A PHYSICIAN STATED THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO THE DEVICE 5F/115CM SEMI-FLOATING BIPOLAR/TEMPORARY PACING/PROT. PIN WITH PRODUCT CODE 006225P TEMPORARY PACING ELECTRODE AND THE PATIENT EXPERIENCED ARRYTHMIA (VENTRICULAR TACHYCARDIA, VENTRICULAR FIBRILLATION), PERFORATION (ARTERIAL OR CARDIAC) AND PULMONARY EMBOLISM. THIS RESULTED IN THE PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 04JUN2024, PHYSICIAN ALSO INDICATED CATHETER DISPLACEMENT OCCURRED AFTER DEVICE PLACEMENT. THE PHYSICIAN INDICATED THIS COMPLICATION TO BE A PROCEDURE RELATED COMPLICATION.

  Patient problems: Arrhythmia; Cardiac Perforation; Perforation; Tachycardia; Ventricular Fibrillation

  MAUDE report 19407287 ↗
• MalfunctionSep 19, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT IN AN ONLINE SURVEY, A PHYSICIAN STATED THAT NO, THEY WERE NOT ABLE TO SUCCESSFULLY PLACE THE ELECTRODE (ABILITY TO PLACE ELECTRODE) BECAUSE OF AN EMERGENCY CASE IN RELATION TO 006225P-5F/115CM SEMI-FLOATING BIPOLAR/TEMPORARY PACING/PROT. PIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775519 ↗
• MalfunctionSep 13, 2023No Pacing; No Pacing

  IT WAS REPORTED THAT A PHYSICIAN IN AN ONLINE SURVEY STATED THAT THE DEVICE WAS NOT SUCCESSFUL IN ABILITY TO PACE BECAUSE "NO CAPTURE" IN RELATION TO THE TEMPORARY PACING ELECTRODE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17737914 ↗
• MalfunctionAug 31, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PHYSICIAN IN AN ONLINE SURVEY STATED THAT THEY WERE NOT ABLE TO SUCCESSFULLY PLACE THE ELECTRODE (ABILITY TO PLACE ELECTRODE) BECAUSE OF DIFFICULT ANATOMY AND SEVERE TRICUSPID REGURGITATION IN RELATION TO THE SEMI-FLOATING BIPOLAR TEMPORARY PACING ELECTRODE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17660858 ↗
• MalfunctionDec 3, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTION OF TEMPORARY PACING ELECTRODE CATHETERS HAD DISCONNECTED ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923922 ↗