Supreme™ 401443Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734201377), received between Jul 18, 2018 and Apr 16, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2024Entrapment of Device; Fracture; Entrapment of Device; Fracture

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, THE ADVISOR HD GRID AND THE SUPREME CATHETER BECAME ENTANGLED TOGETHER WITHIN THE FAST-CATH INTRODUCER. THIS RESULTED IN FRACTURES ON THE ADVISOR HD GRID AND THE SUPREME CATHETER. THE DEVICES WERE UNTANGLED INSIDE THE PATIENT WITHOUT ANY INTERVENTION. THE FAST-CATH INTRODUCER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122673 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MFR NUMBERS: 3008452825-2020-00536, 3005334138-2020-00479, 3005334138-2020-00478. DURING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED, A PERICARDIOCENTESIS WAS PERFORMED, AND THE CASE WAS ABANDONED. A NON-ABBOTT CRYO-BALLOON ABLATION CATHETER WAS USED AFTER TRANSSEPTAL PUNCTURE ON THE LEFT SUPERIOR PULMONARY VEIN AND LEFT INFERIOR PULMONARY VEIN. WHEN IT WAS USED TO CRYO-ABLATE THE RIGHT INFERIOR PULMONARY VEIN, PHRENIC NERVE PACING STOPPED SIMULATING THE RIGHT HEMI-DIAPHRAGM. THE CATHETER WAS REPOSITIONED IN THE SUPERIOR VENA CAVA NUMEROUS TIMES TO TRY TO REESTABLISH PHRENIC NERVE STIMULATION. CRYO WAS STOPPED, THE BALLOON CATHETER WAS REMOVED AND REPLACE WITH A TACTICATH SE. THE TACTICATH SE WAS USED FOR RADIO FREQUENCY WIDE-AREA CIRCUMFERENTIAL ABLATION NEAR THE RIGHT INFERIOR PULMONARY VEIN. HYPOTENSION WAS NOTED, AND THE ICE CATHETER SHOWED A PERICARDIAL EFFUSION. ABLATION WAS STOPPED, CATHETERS WERE REMOVED, AND PERICARDIOCENTESIS WAS STARTED. THE PERICARDIOCENTESIS REMOVED 450ML FROM THE EFFUSION. THE PATIENT WAS INTUBATED AND WENT TO THE ICU. IT WAS NOT CLEAR WHICH CATHETER OR MANEUVER CAUSED THE EFFUSION, OR WHERE THE SUSPECTED PERFORATION WAS

  Patient problems: Cardiac Perforation

  MAUDE report 10754674 ↗
• InjuryFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2030404-2020-00012, 3008452825-2020-00112, 2182269-2020-00020, 2182269-2020-00021, 2182269-2020-00022, 2030404-2020-00013, 3005334138-2020-00072. DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT BECAME HYPOTENSIVE, SO AN ULTRASOUND WAS PERFORMED, CONFIRMING A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9744990 ↗
• MalfunctionJul 18, 2018Difficult to Remove; Difficult to Remove

  DURING INSERTION OF THE CATHETER FROM THE LEFT VENTRICLE, THE CATHETER DID NOT ADVANCE INTO THE RIGHT ATRIUM AS INTENDED. THE CATHETER HAD FORMED A KNOT TOWARDS THE DISTAL END WHICH COULD NOT BE UNDONE. A SNARE WAS ADVANCED OVER THE KNOT AND THE CATHETER WAS PULLED BACK THROUGH THE SNARE, UNTYING ITSELF IN THE PROCESS. THE SNARE AND CATHETER WERE SAFELY RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7697628 ↗

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