Skip to content

Tempo Temporary Pacing Lead, Curved TC1106Recalls & reported problems

Bio Trace Medical · The BioTrace Medical Tempo Temporary Pacing Lead is designed for temporary intracardia pacing. The lead provides access to the right ventricle via either the femoral vein, subclavian vein or the internal jugular vein approach and may be shaped near the distal end to facilitate delivery. It is a radiopaque, polymeric lead featuring a balloon , active fixations, bipolar electrodes and a soft tip. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10866899000210), received between Jan 17, 2020 and Jan 17, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

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

Device problems

  • Material Fragmentation1

Patient problems

  • Pericardial Effusion1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 17, 2020Material Fragmentation; Material Fragmentation

    DURING THE PROCEDURE THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. DR. (B)(6) WHO PLACED THE TEMPO LEAD STATED THAT HE BELIEVED THAT THE PERFORATION OCCURRED DURING THE INITIAL PLACEMENT OF THE TEMPO LEAD. THIS IS SUPPORTED BY HIS STATEMENT THAT THE TEMPO LEAD WAS PLACED "WAY OUT" TO THE APEX OF THE RIGHT VENTRICLE AND IN SPITE OF THIS TYPICALLY OPTIMAL POSITION, PACE CAPTURE COULD NOT BE ATTAINED. DR. (B)(6) REPOSITIONED THE TEMPO LEAD TWICE AND WAS ULTIMATELY ABLE TO OBTAIN A CAPTURE THRESHOLD BELOW 1MA (GENERALLY CONSIDERED OPTIMAL). SUBSEQUENT TO PLACEMENT OF THE LEAD THE PATIENT WAS NOTED TO BE HYPOTENSIVE, WHICH WAS ULTIMATELY DETERMINED TO BE RELATED TO A PERICARDIAL EFFUSION. SURGERY WAS PERFORMED ON THE PATIENT TO CLOSE A SMALL PERFORATION IN THE APEX OF THE HEART. DR (B)(6) STATED THAT HE USED THE INTRODUCER AID TO ADVANCE THE TEMPO LEAD INTO THE INTRODUCER SHEATH AND THAT HE DID NOT HAVE ANY DIFFICULTY DURING TEMPO LEAD INSERTION OR PLACEMENT. HE STATED THAT THE SOFT TIP LOOKED NORMAL AT THE TIME OF THE FINAL POSITION IN THE APEX OF THE RIGHT VENTRICLE AND WAS NOT KINKED OR "OFFSET". HE ALSO STATED THAT THE PATIENT WAS (B)(6) AND AT RISK OF AN APICAL PERFORATION BY VIR

    Patient problems: Pericardial Effusion

    MAUDE report 9603633 ↗

Other Electrode, Pacemaker, Temporary devices

All Electrode, Pacemaker, Temporary devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page