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Supreme™ 401864Recalls & reported problems

St. Jude Medical Cardiovascular Division · Electrophysiology Catheter · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734201544), received between Aug 9, 2021 and Aug 9, 2021 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K894500); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Frayed1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionAug 9, 2021Material Frayed; Material Frayed

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A EXPOSED INTERNAL WIRING ON THE CATHETER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12294974 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K894500. One submission often covers many models, so check the product and lot details in each record.

  • Z-0177-2015 · Oct 14, 2014 · Terminated
    St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353

Other CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices

All CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.