N/A 006241PRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741011238), received between Jan 17, 2020 and Aug 17, 2026 — classified as 3 injuries, 3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026No Pacing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287025 ↗
• MalfunctionAug 14, 2026No Pacing

  Patient problems: Insufficient Information

  MAUDE report 50254336 ↗
• 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 "6F 125CM SEMI-FLOATING TEMPORARY PACING ELECTRODE CATHETER, BIPOLAR" WITH PRODUCT CODE 006241P, AND THE PATIENT EXPERIENCED "INFECTION" LOCATED IN "BELLY", AND IT DID NOT RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Unspecified Infection

  MAUDE report 22473408 ↗
• InjuryJul 10, 2025No Pacing; No Pacing

  IT WAS REPORTED THAT IN THE ONLINE SURVEY A PHYSICIAN STATED THAT "NO, THE ELECTRODE WAS NOT SUCCESSFULLY ABLE TO CAPTURE AND PACE FOR THE CHOSEN DURATION OF USE¿ BECAUSE "TAMPONADE" IN RELATION TO THE DEVICE "6F 125CM SEMI-FLOATING TEMPORARY PACING ELECTRODE CATHETER, BIPOLAR" WITH PRODUCT CODE 006241P.

  Patient problems: Cardiac Tamponade

  MAUDE report 22472728 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED PERFORATION (ARTERIAL OR CARDIAC) PRIOR TO THE DEVICE PLACEMENT AND PULMONARY EMBOLISM, BACTERIAL INFECTION IN GROIN COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE AND PTE WAS NEEDED FOR PULMONARY EMBOLISM AND GROIN WAS NEEDED FOR INFECTION IN RELATION TO 006241P - 6F/125CM SEMI-FLOATING BIPOLAR/TEMPORARY PACING/PROT. PIN. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Bacterial Infection; Pulmonary Embolism

  MAUDE report 17627532 ↗
• MalfunctionJan 17, 2020Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THERE WAS KINKING ON THE PROXIMAL SEGMENT OF THE PACING LEAD.

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

  MAUDE report 9601998 ↗