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Tempo Temporary Pacing Lead T1106Recalls & reported problems

Bio Trace Medical · The BioTrace Medical Tempo Temporary Pacing Lead is designed for temporary intracardiac 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 fixation, bipolar electrodes and a soft tip. · Class 2

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

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10866899000203), received between Sep 13, 2019 and Nov 1, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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

Device problems

  • Material Fragmentation2
  • Mechanical Problem1
  • Retraction Problem1

Patient problems

  • No Known Impact Or Consequence To Patient2
  • Pericardial Effusion1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 1, 2019Material Fragmentation; Material Fragmentation

    (B)(6) HOSPITAL REPORTED THAT THEY EXPERIENCED A CASE WHEREIN THE TIP OF THE DEVICE HAD BEEN DAMAGED AND A FRAGMENT WAS MISSING. UPON FURTHER DISCUSSION VIA PHONE, IT WAS COMMUNICATED THAT THE TIP COULD NOT BE LOCATED WITHIN THE PATIENT UNDER XRAY. BTMI ADVISED THAT THE TIP IS RADIOPAQUE. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS COMPLAINT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9267971 ↗
  • MalfunctionOct 26, 2019Mechanical Problem; Retraction Problem; Mechanical Problem; Retraction Problem

    (B)(6) HOSPITAL CONTACTED BIOTRACE MEDICAL AND COMMUNICATED THAT THEY HAD EXPERIENCED A CASE WHERE THEY HAD AN ISSUE WITH STABILIZER RETRACTION: "I HAVE A TEMPO WIRE THAT THE STABILIZERS DID NOT RETRACT WHEN THE MD WAS REMOVING THE WIRE." THERE WAS NO PATIENT INJURY ASSOCIATED WITH THE COMPLAINT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9243283 ↗
  • InjurySep 13, 2019Material Fragmentation; Material Fragmentation

    UPON REMOVAL OF THE LEAD FROM THE PATIENT, A PERICARDIAL EFFUSION WAS NOTED ON ECHOCARDIOGRAM. THE EFFUSION DID NOT REQUIRE INTERVENTION. IT WAS OBSERVED THAT THE SOFT TIP OF THE LEAD WAS DETACHED AT THE MIDPOINT OF THE TIP.

    Patient problems: Pericardial Effusion

    MAUDE report 9038803 ↗

Other Electrode, Pacemaker, Temporary devices

All Electrode, Pacemaker, Temporary devices →

Sources and updates

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