Supreme™ 401436Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734201322), received between Jan 13, 2021 and Apr 1, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2021Material Frayed; Material Frayed

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING EXPOSED WIRES OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11603377 ↗
• MalfunctionMar 31, 2021Break; Break

  THIS REPORT IS TO ADVISE OF AN EVENT NOTED DURING ANALYSIS REVEALING EXPOSED INTERNAL WIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595245 ↗
• MalfunctionJan 13, 2021Fracture; Fracture

  DURING THE SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE CATHETER TIP WAS BROKEN. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11163068 ↗

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