Supreme™ 401430Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05414734201285), received between Jun 15, 2018 and Sep 17, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Fracture; Fracture

  DURING AN ABLATION PROCEDURE, AFTER INSERTION INTO THE PATIENT, THE CATHETER APPEARANCE LOOKED WRONG ON FLUOROSCOPY. THE CATHETER WAS REMOVED AND WAS NOTED TO BE FRACTURED AT THE DISTAL END BETWEEN THE CURVE AND THE SHAFT. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077672 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE FOR A LEFT VENTRICLE LEAD PLACEMENT, A CORONARY SINUS DISSECTION WAS OBSERVED VIA FLUOROSCOPY AFTER INSERTING THE SUPREME CATHETER. THE DISSECTION WAS VERY SMALL, WITH NO PERICARDIAL EFFUSION. THE PHYSICIAN PAUSED THE PROCEDURE FOR 10 MINUTES AND THE DISSECTION REABSORBED ITSELF. THE LEFT VENTRICLE LEAD PROCEDURE WAS THEN COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Vascular Dissection

  MAUDE report 12861997 ↗
• InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE FOR AN IMPLANT OF A BIVENTRICULAR PACEMAKER, A DISSECTION OF THE CORONARY SINUS WAS NOTED VIA FLUOROSCOPY. THE CAUSE OF THE DISSECTION WAS THOUGHT TO HAVE POTENTIALLY BEEN THE DIAGNOSTIC CATHETER. THE DIAGNOSTIC CATHETER WAS USED TO CANNULATE THE CORONARY SINUS. THE BIVENTRICULAR ICD WAS STILL IMPLANTED. THE PATIENT WAS NOTED TO BE STABLE AND NO INTERVENTION WAS CONDUCTED. THERE WERE NO PERFORMANCE ISSUES WITH THE DEVICE.

  Patient problems: Vascular Dissection

  MAUDE report 12280056 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE TO EXTRACT THE LEFT VENTRICLE LEAD, A DISSECTION OCCURRED. WHILE CANNULATION OF THE CORONARY SINUS, BY FLUOROSCOPIC VIEW, IT WAS POSSIBLE TO SEE A LITTLE DISSECTION OF THE CORONARY SINUS, WHICH RESOLVED WITH NO INTERVENTION. THE PATIENT IS CURRENTLY IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Vascular Dissection

  MAUDE report 11024514 ↗
• InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2020-00399, 3008452825-2020-00404, 3008452825-2020-00405, 2182269-2020-00071. DURING A PREMATURE VENTRICULAR CONTRACTION (PVC) PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER 2 HOURS, THE PATIENT BECAME HYPOTENSIVE AND AN ULTRASOUND REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS STABLE WHEN LEAVING THE ROOM. HOWEVER, THE PATIENT WAS THEN TRANSFERRED TO SURGERY FOR REPAIR AND IS IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 10414091 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ABLATION PROCEDURE A DISSECTION OCCURRED. WHILE PLACING THE SUPREME CATHETER THE CORONARY SINUS WAS DISSECTED. FLUOROSCOPY AND CONTRAST WERE USED TO CONFIRM THE DISSECTION HOWEVER THERE WERE NO PATIENT SYMPTOMS AND NO INTERVENTION WAS NEEDED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Vascular Dissection

  MAUDE report 9341662 ↗
• InjuryJul 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ICD IMPLANT PROCEDURE, A SUBCLAVIAN VEIN DISSECTION OCCURRED. ANGIOGRAPHY CONFIRMED A CLEAR PATH TO THE SUPERIOR VENA CAVA (SVC). AFTER INSERTING THE GUIDEWIRE AND INTRODUCER, THE LEAD AND CATHETER WERE ADVANCED UNDER FLUOROSCOPIC GUIDANCE. RESISTANCE WAS NOTED BETWEEN THE SVC AND SUBCLAVIAN VEIN. THE LEAD WAS ADVANCED TO THE TIP OF THE CATHETER AND THE CATHETER WAS PUSHED FORWARD AND PASSED THE RESISTANCE. AT THAT MOMENT, THE PATIENT COMPLAINED OF CHEST PAIN. CONTRAST FLUID WAS INJECTED AND WAS OBSERVED SPREADING THROUGH THE MEDIASTINUM CONFIRMING A DISSECTED AREA WHERE THE VEIN MADE A 90 DEGREE ANGLE. THE PATIENT WAS TRANSFERRED FOR VASCULAR SURGERY AND IS IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 8792743 ↗
• InjuryJun 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CRT-D IMPLANT PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. WHILE CANNULATING THE CORONARY SINUS FOR LEFT LEAD PLACEMENT, A PERICARDIAL EFFUSION WAS VISUALIZED WHEN INJECTING CONTRAST MEDIUM. THE PATIENT REMAINED ASYMPTOMATIC AND A PERICARDIOCENTESIS WAS PERFORMED. THE PHYSICIAN DECIDED NOT TO IMPLANT THE CRT-D DEVICE AND INSTEAD IMPLANTED AN ICD. THE PATIENT WAS TRANSFERRED TO THE CARDIOTHORACIC UNIT FOR MONITORING AND WAS LATER DISCHARGED IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Perforation of Vessels

  MAUDE report 7604912 ↗

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