Supreme™ 401442Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734201360), received between Jun 22, 2018 and Feb 18, 2020 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• DeathFeb 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CRT-D IMPLANTATION PROCEDURE A CARDIAC TAMPONADE AND SUBSEQUENT PATIENT EXPIRATION OCCURRED. THE DIAGNOSTIC CATHETER WAS USED FOR CORONARY SINUS (CS) CANNULATION. WHILE IMPLANTING THE LEADS THERE WAS DIFFICULTY ADVANCING PAST THE CS BUT EVENTUALLY THE LEADS WERE ABLE TO OVERPASS THE VALVE. ONCE PAST THE VALVE THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAM REVEALED BLOOD IN THE PERICARDIUM. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT HOWEVER CARDIOPULMONARY RESUSCITATION WAS NEEDED. THE PATIENT EXPIRED FOLLOWING INTERVENTION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation; Death

  MAUDE report 9720001 ↗
• InjurySep 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MANUFACTURING RELATED REF: 3005334138-2019-00502. DURING THE PROCEDURE, WHEN ATTEMPTING TO REMOVE THE HD GRID CATHETER, IT BECAME ENTANGLED IN ANOTHER MAPPING CATHETER THAT WAS WITHIN THE RIGHT ATRIUM. THE HD GRID CATHETER WAS ABLE TO BE REMOVED BUT THE DISTAL PORTION OF THE OTHER MAPPING CATHETER BECAME DETACHED. ALL PORTIONS OF THE CATHETER WERE ABLE TO BE REMOVED FROM THE PATIENT WITH THE HD GRID CATHETER. THE HD GRID CATHETER WAS THEN ABLE TO BE USED TO CONTINUE AND COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8995930 ↗
• InjuryJun 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 9680001-2018-00084, 3005334138-2018-00174, 3008452825-2018-00195, 2182269-2018-00080, 3008452825-2018-00196, 3008452825-2018-00198. DURING A VENTRICULAR TACHYCARDIA PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AN ELDERLY PATIENT WHO WAS VERY PRO-ARRHYTHMIC DURING THE VT PROCEDURE, WITH A SYSTOLIC BLOOD PRESSURE (SBP) OF 100 FROM THE INITIATION OF THE PROCEDURE. WHILE THE TACTICATH WAS BEING MANIPULATED IN THE VENTRICLE, THE PATIENT'S SBP DECREASED TO 85-90, THE PROCEDURE WAS PAUSED AND AFTER 30 MINUTES THE BP REMAINED LOW AN ECHOCARDIOGRAM REVEALED A SMALL PERICARDIAL EFFUSION. WHILE PREPPING TO PERFORM A PERICARDIOCENTESIS THE PATIENT'S BP DROPPED AND THE PATIENT DECOMPENSATED. A CATHETER WAS INTRODUCED INTO THE CORONARY SINUS FOR PACING AND A PERICARDIOCENTESIS AND BLOOD TRANSFUSION WERE PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 7630752 ↗

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