SupremeRecalls & reported problems across all models
St. Jude Medical Cardiovascular Division · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 43
- Deaths reported
- 1
- Injuries reported
- 22
- Recalls
- 0
We found 16 models of Supreme by St. Jude Medical Cardiovascular Division in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between Jun 15, 2018 and Oct 31, 2025 — classified as 1 death, 22 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Fracture” (10 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Supreme problems
Device problems
- Adverse Event Without Identified Device or Use Problem19
- Fracture10
- Difficult to Remove4
- Communication or Transmission Problem3
- Material Frayed3
- Entrapment of Device2
- Material Separation2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Cardiac Perforation13
- No Consequences Or Impact To Patient8
- Vascular Dissection5
- Death1
- Foreign Body In Patient1
- Perforation of Vessels1
Supreme models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Supreme™ 401430CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING8 reports
- Supreme™ 402004CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING6 reports
- Supreme™ 401443CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING4 reports
- Supreme™ 401450CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING4 reports
- Supreme™ 401436CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING3 reports
- Supreme™ 401442CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 death3 reports
- Supreme™ 401449CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 reports
- Supreme™ 401451CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 reports
- Supreme™ 401860CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 reports
- Supreme™ 401877CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 reports
- Supreme™ 401994CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 reports
- Supreme™ 401434CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- Supreme™ 401864CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- Supreme™ 401878CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- Supreme™ 401890CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- Supreme™ 401956CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
Recent Supreme adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2025Fracture; Fracture
DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE CATHETER FRACTURED WHILE INSERTED IN THE PATIENT. THE CATHETER WAS PLACED IN THE RIGHT ATRIUM THROUGH THE SUPERIOR VENA CAVA WHEN IT WAS NOTICED ON X-RAY THAT THE EXTERNAL DISTAL PART OF THE CATHETER WAS FRACTURED WITH JUST THE INNER WIRE CONNECTING THE TWO PARTS. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23433495 ↗InjuryOct 28, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA PROCEDURE, THE CATHETER BECAME TANGLED AROUND ITSELF WHEN GOING UP THE ILIAC VEIN. IT WAS ATTEMPTED TO UNTANGLE IT BUT SUPPORT FROM AN INTERVENTIONAL SURGEON WAS REQUIRED. WHEN ATTEMPTING TO REMOVE THE CATHETER, IT BROKE AND THE KNOT THAT HAD FORMED WAS STUCK IN THE VEIN. A VASCULAR SURGEON WAS THEN CALLED TO REMOVE THE KNOT THAT REMAINED. THE KNOT WAS REMOVED WITH EASE AFTER THE INITIAL INCISION WAS CUT A LITTLE LARGER THAN BEFORE.
Patient problems: Foreign Body In Patient
MAUDE report 23405777 ↗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 ↗MalfunctionJul 29, 2025Fracture; Fracture
DURING THE ATRIAL FIBRILLATION PROCEDURE, WHEN ADVANCING THE CATHETER, IT WAS NOTED TO BE DIFFICULT TO MANEUVER. THE CATHETER WAS REMOVED FROM THE PATIENT, AND A FRACTURE WAS FOUND ON PART OF THE CATHETER. 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 22645102 ↗MalfunctionApr 21, 2025Fracture; Fracture
DURING THE PROCEDURE, A BREAK OCCURRED IN THE CATHETER. THE CATHETER WAS INTRODUCED VIA FEMORAL VENOUS WAY AND PLACED IN THE CORONARY SINUS WITHOUT DIFFICULTY. DURING INTRODUCTION OF THE SECOND CATHETER, X-RAY SHOWED DISCONTINUITY OF THE CATHETER. UPON REMOVAL OF THE DEVICE, A SEPARATION WAS NOTED BETWEEN THE BODY OF THE CATHETER AND THE DISTAL PART, WITH EXPOSURE OF THE COPPER CONDUCTORS NOTED. THERE WERE NO PATIENT CONSEQUENCES. THE PIECE IS RETAINED BY THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21874501 ↗MalfunctionJan 22, 2025Communication or Transmission Problem; Communication or Transmission Problem
DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE CATHETERS WERE NOT VISUALIZED AND NO ELECTROGRAMS WERE APPARENT WHICH CAUSED A DELAY IN PROCEDURE. BOTH CATHETERS WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21210010 ↗MalfunctionJan 22, 2025Communication or Transmission Problem; Communication or Transmission Problem
DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE CATHETERS WERE NOT VISUALIZED AND NO ELECTROGRAMS WERE APPARENT WHICH CAUSED A DELAY IN PROCEDURE. BOTH CATHETERS WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21210004 ↗MalfunctionJun 24, 2024Fracture; Fracture
THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER SHAFT DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19601663 ↗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 ↗MalfunctionFeb 7, 2024Fracture; Difficult to Insert; Material Twisted/Bent; Fracture; Difficult to Insert; Material Twisted/Bent
DURING THE ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE, WHEN INSERTING THE CATHETER THROUGH THE FEMORAL VEIN ACCESS, RESISTANCE WAS MET. MORE FORCE WAS USED WITH NO RESOLUTION. THE CATHETER WAS REMOVED AND IT WAS NOTED TO BE FRACTURED AND BENT. THE CATHETER AND INTRODUCER WERE BOTH REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18659508 ↗MalfunctionDec 6, 2022Communication or Transmission Problem; Communication or Transmission Problem
DURING EMERGENCY IMPLANTATION OF AN ELECTROSYSTOLIC TRAINING PROBE FOR A PATIENT WITH COMPLETE BAV WITH ISCHEMIC HEART DISEASE, THERE WAS AN ISSUE WITH THE PACING LEAD RESULTING IN A DELAY OF PROCEDURE. THE STIMULATION GENERATOR AND CONNECTION CABLE WERE CHANGED BEFOREHAND BUT DID NOT RESOLVE THE ISSUE. THE CATHETER WAS CHANGED AND THE ISSUE RESOLVED WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15925499 ↗MalfunctionMay 26, 2022Entrapment of Device; Entrapment of Device
RELATED MANUFACTURING REF: 3008452825-2022-00441. DURING THE PROCEDURE, THE CATHETERS BECAME ENTANGLED WITH EACH OTHER. WHILE MAPPING IN THE RIGHT ATRIUM, THE HD GRID CATHETER WENT INTO THE RIGHT VENTRICLE (RV) AND THE RV CATHETER (JSN) WENT THROUGH THE OPENING BETWEEN THE SPLINES OF THE HD GRID CATHETER. THE PHYSICIAN WAS UNAWARE THAT THE RV CATHETER WENT THROUGH THE SPLINES AND PULLED THE HD GRID CATHETER BACK INTO THE SRO SHEATH TO REMOVE IT. WHEN DOING SO, THE JSN CATHETER WAS PULLED INTO THE SHEATH AND PULLED HARDER TO REMOVE HD GRID. FLUOROSCOPY REVEALED THE JSN CATHETER WAS DOUBLED OVER AND STICKING OUT OF THE TOP OF THE SRO SHEATH. BOTH CATHETERS WERE STUCK IN THE SHEATH. TECH SERVICES WAS CONTACTED AND WHILE ON THE PHONE, THE PHYSICIAN PUSHED AND THE TWO CATHETERS FINALLY CAME OUT THE DISTAL END OF THE SRO AND WAS ABLE TO REMOVE THE JSN, THEN THE GRID. BOTH CATHETERS WERE INTACT, BUT BENT. THERE WAS NO HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14518588 ↗InjuryMay 26, 2022Material Separation; Material Separation
DURING THE PROCEDURE, WHEN ATTEMPTING TO EXCHANGE THE DEVICE AND PULLING ON THE CATHETER, THE SHAFT BROKE INTO 2 PIECES. THERE WERE NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14515545 ↗InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURING REF: 2182269-2022-00026 AND 3008452825-2022-00407. DURING A SUPRAVENTRICULAR ABLATION PROCEDURE WITH WOLFE PARKINSON WHITE SYNDROME, A PERICARDIAL EFFUSION WAS NOTED IN THE CORONARY SINUS. DURING THE PROCEDURE, ELECTRODE 7-8 OF THE STEERABLE CATHETER SHOWED NOISE AND STRETCHING ON THE SYSTEM SCREEN AND THE PHYSICIANS INVOLVED STATED HIGH IMPEDANCE WAS NOTED. THE SIGNALS OF CS 7-8 WERE HIDDEN FROM BOTH THE ENSITE PRECISION AND THE EP RECORDING SYSTEM TO CONTINUE THE PROCEDURE. ACCESS THE CORONARY SINUS (CS) WAS ATTEMPTED WITH THE STEERABLE CATHETER, AND SUBSEQUENTLY WITH THE HELP OF THE SL3 SHEATH. A NON ABBOTT GUIDEWIRE WAS THEN USED TO GUIDE THE CS CATHETER. AFTER THE CATHETERS WERE IN PLACE, THE STUDY WAS PERFORMED. THE PATIENT THEN BECAME RESTLESS AND STATS DROPPED TO APPROXIMATELY 70+. AN ECHO WAS THEN PERFORMED WHICH REVEALED AN EFFUSION. HOWEVER, THE PROCEDURE WAS ABANDONED MIDWAY THROUGH THE STUDY AS THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION WHICH WAS CONFIRMED VIA ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT.
Patient problems: Cardiac Perforation
MAUDE report 14306285 ↗InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURING REF: 2182269-2022-00026, 3008452825-2022-00408. DURING A SUPRAVENTRICULAR ABLATION PROCEDURE WITH WOLFE PARKINSON WHITE SYNDROME, A PERICARDIAL EFFUSION WAS NOTED IN THE CORONARY SINUS. DURING THE PROCEDURE, ELECTRODE 7-8 OF THE STEERABLE CATHETER SHOWED NOISE AND STRETCHING ON THE SYSTEM SCREEN AND THE PHYSICIANS INVOLVED STATED HIGH IMPEDANCE WAS NOTED. THE SIGNALS OF CS 7-8 WERE HIDDEN FROM BOTH THE ENSITE PRECISION AND THE EP RECORDING SYSTEM TO CONTINUE THE PROCEDURE. ACCESS THE CORONARY SINUS (CS) WAS ATTEMPTED WITH THE STEERABLE CATHETER, AND SUBSEQUENTLY WITH THE HELP OF THE SL3 SHEATH. A NON ABBOTT GUIDEWIRE WAS THEN USED TO GUIDE THE CS CATHETER. AFTER THE CATHETERS WERE IN PLACE, THE STUDY WAS PERFORMED. THE PATIENT THEN BECAME RESTLESS AND STATS DROPPED TO APPROXIMATELY 70+. AN ECHO WAS THEN PERFORMED WHICH REVEALED AN EFFUSION. HOWEVER, THE PROCEDURE WAS ABANDONED MIDWAY THROUGH THE STUDY AS THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION WHICH WAS CONFIRMED VIA ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT.
Patient problems: Cardiac Perforation
MAUDE report 14306196 ↗
Other St. Jude Medical Cardiovascular Division products
All St. Jude Medical Cardiovascular Division devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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