Supreme™ 401877Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734201612), received between Oct 3, 2018 and Sep 25, 2019 — classified as 2 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, A CARDIAC PERFORATION OCCURRED. NEAR THE END OF THE PROCEDURE, THE CORONARY SINUS CATHETER NEAR THE RIGHT VENTRICULAR APEX HAD CHANGED LOCATION ON THE MAPPING SYSTEM. A TRANSIENT DECREASE IN BLOOD PRESSURE OCCURRED AND FLUID WAS OBSERVED IN THE RIGHT VENTRICULAR PERICARDIAL SPACE. ECHOCARDIOGRAPHY REVEALED A SMALL PERFORATION. NO INTERVENTION WAS NEEDED TO REMOVE THE PERICARDIAL FLUID. THERE WERE NO PERFORMANCE ISSUES WITH THE DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9116442 ↗
• InjuryOct 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  9680001-2018-00149, 3008452825-2018-00341, 2182269-2018-00122. FOLLOWING A VT ABLATION PROCEDURE, A TAMPONADE OCCURRED. THE PROCEDURE WAS COMPLETED WITH NO PERFORMANCE ISSUES NOTED AND AN ECHOCARDIOGRAM IMMEDIATELY FOLLOWING THE PROCEDURE WAS NORMAL. THE DAY FOLLOWING, THE PATIENT DIDN¿T FEEL WELL. AN ECHOCARDIOGRAM REVEALED A TAMPONADE FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 7931536 ↗

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