NBIH™ Temporary Pacing Electrode Catheter 007152PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741011283), received between Jun 26, 2018 and Mar 26, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2019Nonstandard Device; Material Too Rigid or Stiff; Nonstandard Device

  IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE SEEMED STIFFER THAN USUAL AND WAS DIFFICULT TO "LOOP." THE DOCTOR ALLEGES THAT THE STIFFNESS OF THE DEVICE HAS CHANGED IN THE PREVIOUS YEAR. IT WAS ALSO STATED DURING PLACEMENT OF THE DEVICE, THE PATIENT CODED. SUBSEQUENTLY, THE PATIENT HAD TO HAVE AN ANGIOPLASTY, BALLOON PUMP, AND A TEMPORARY PACEMAKER PLACED DUE TO THEIR CARDIAC CONDITION.

  Patient problems: Cardiac Arrest; Cardiopulmonary Arrest; No Code Available

  MAUDE report 8452598 ↗
• InjuryJun 26, 2018Nonstandard Device; Material Too Rigid or Stiff; Nonstandard Device

  IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE SEEMED STIFFER THAN USUAL. THE PATIENT ALLEGEDLY EXPERIENCED CARDIAC TAMPONADE AND REQUIRED AN ADDITIONAL SURGERY.

  Patient problems: Cardiac Tamponade

  MAUDE report 7639442 ↗