Supreme™ 401956Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734201803), received between Dec 6, 2022 and Dec 6, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Communication or Transmission Problem” (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

Recent adverse event reports

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

• MalfunctionDec 6, 2022Communication or Transmission Problem; Communication or Transmission Problem

  DURING EMERGENCY IMPLANTATION OF AN ELECTROSYSTOLIC TRAINING PROBE FOR A PATIENT WITH COMPLETE BAV WITH ISCHEMIC HEART DISEASE, THERE WAS AN ISSUE WITH THE PACING LEAD RESULTING IN A DELAY OF PROCEDURE. THE STIMULATION GENERATOR AND CONNECTION CABLE WERE CHANGED BEFOREHAND BUT DID NOT RESOLVE THE ISSUE. THE CATHETER WAS CHANGED AND THE ISSUE RESOLVED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15925499 ↗

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