PREFACERecalls & reported problems across all models

We found 3 models of PREFACE by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 193 adverse event reports in the FDA's MAUDE database, received between Feb 26, 2018 and Sep 9, 2026 — classified as 1 death, 21 injuries, 171 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (61 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

Most reported PREFACE problems

PREFACE models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PREFACE 301803M

  INTRODUCER, CATHETER
  1 death152 reports
• PREFACE 301803MS

  INTRODUCER, CATHETER
  38 reports
• PREFACE 301805M

  INTRODUCER, CATHETER
  3 reports

Recent PREFACE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698426 ↗
• MalfunctionAug 13, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50241523 ↗
• MalfunctionJun 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PREFACE SHEATH AND THE HEMOSTATIC VALVE BROKE. THE HEMOSTATIC VALVE OF THE SHEATH BROKE WHEN REMOVING THE OCTARAY CATHETER. NO SIGNIFICANT BLOOD LOSS WAS OBSERVED AND THE HEMOSTATIC VALVE DID NOT DISLODGE INSIDE THE HUB. IT WAS UNCLEAR IF THE VALVE DISLODGED OUTSIDE OF THE HUB. THE BRIM CAP AND HUB DID NOT DETACH FROM THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25546056 ↗
• MalfunctionJun 17, 2026Material Perforation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION CARDIAC ABLATION PROCEDURE WITH A PREFACE SHEATH AND OBSERVED A RUPTURE (PERFORATION) ON THE DILATOR. PREFACE INTRODUCER WAS OPENED DURING THE PROCEDURE. THE INTERATRIAL SEPTUM WAS ADVANCED AND APPROACHED TO PERFORM A TRANSSEPTAL PUNCTURE BUT THERE WAS EVIDENCE OF LOSS OF THE CURVE DURING FLUOROSCOPY. THE INTRODUCER WAS REMOVED AND RUPTURE AND PASSAGE OF THE DILATOR WAS EVIDENCED BY THE RUPTURE, WHICH IS WHY IT WAS NECESSARY TO REPLACE IT WITH ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. ADDITIONAL INFORMATION WAS RECEIVED. RESISTANCE OCCURRED IN THE HEART BEFORE PERFORMING THE TRANSSEPTAL PUNCTURE. AT NO TIME WAS THE INTERNAL SHEATH MECHANISM EXPOSED TO THE PATIENT; RESISTANCE WAS ENCOUNTERED AND IT WAS WITHDRAWN IMMEDIATELY. THE SOFT TIP BUCKLED. IT WAS NOT OBSERVED THAT THE SHAFT WAS ROUGH; THE INTRODUCER WAS FLUSHED NORMALLY WITH HEPARINIZED SOLUTION, AND THE TRANSSEPTAL NEEDLE ADVANCED SMOOTHLY WITHOUT ISSUE. IT WAS NOT OBSERVED TO BE OUTSIDE THE INSTRUCTIONS FOR USE (IFU) SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536079 ↗
• InjuryJun 10, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. ECHOCARDIOGRAPHY REVEALED A PERICARDIAL EFFUSION CAUSING CARDIAC TAMPONADE. THE BLOOD WAS DRAINED AND THE PATIENT WAS STABILIZED. THE PATIENT WENT TO THE ICU (INTENSIVE CARE UNIT) AND WAS STABLE FOR TWO HOURS AFTER THE PROCEDURE. THE PHYSICIAN SUSPECTED THAT IT MAY HAVE OCCURRED DURING TRANSSEPTAL PUNCTURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 25462738 ↗
• MalfunctionJun 4, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A PREFACE SHEATH AND WHEN REMOVING THE DEVICE FROM ITS PACKAGING, THE HEMOSTATIC VALVE 'FELT DIFFERENT FROM USUAL'. THE PHYSICIAN TOUCHED THE SHEATH AND FELT A 'SENSE OF ABNORMALITY', NOTING THAT THE VALVE APPEARED TO BE LOOSELY SECURED TO THE REST OF THE DEVICE. AFTER A PERIOD OF OBSERVATION, THE PHYSICIAN DECIDED THAT THEY WOULD BE UNCOMFORTABLE USING THE DEVICE, AND DECIDED TO REPLACE THE SHEATH. THE PROCEDURE WAS THEN COMPLETED WITH A NEW PREFACE SHEATH 'WITHOUT ANY SENSE OF ABNORMALITY' OR DEFECT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399130 ↗
• MalfunctionMay 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PREFACE SHEATH AND WHEN OPENING THE DEVICE THE DOCTOR NOTICED THAT AIR LEAKED FROM THE HEMOSTATIC VALVE. THIS DEVICE WAS NEVER USED ON THE PATIENT. THE PHYSICIAN DECIDED TO IMMEDIATELY CHANGE TO A NEW SHEATH AND CONTINUE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25102498 ↗
• MalfunctionApr 22, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A VIZIGO SHEATH AND WHEN TAKING THE DEVICE OUT OF THE BAG FOR USE, THE HEMOSTATIC VALVE FELT DIFFERENT FROM USUAL, AND THERE WAS A SENSE OF ABNORMALITY (THE VALVE APPEARED TO BE LOOSELY SECURED), CAUSING CONCERN TO THE PHYSICIAN. THE DEVICE WAS NOT USED ON THE PATIENT. THE PHYSICIAN REPLACED THE SHEATH AND CONTINUED THE PROCEDURE. THE CASE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957521 ↗
• InjuryApr 20, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION WITH A PREFACE SHEATH AND THE PATIENT EXPERIENCED A THROMBOSIS. A TRANSSEPTAL PUNCTURE WAS PERFORMED. HOWEVER, BECAUSE THE PATIENT WAS VERY TALL, THE PREFACE SHEATH DID NOT REACH PROPERLY, SO THE DOCTOR COULD NOT SECURE IT IN THE SEPTUM TO SUBSEQUENTLY ADVANCE THE CATHETER. AFTER SEVERAL ATTEMPTS (AND NO HEPARIN WAS GIVEN), A THROMBUS FORMED NEAR THE FOSSA IN THE LEFT ATRIUM. THE PROCEDURE WAS CANCELLED IMMEDIATELY. THE THROMBUS DISLODGED. THE PATIENT WOKE UP, AND AFTER A NEUROLOGICAL EXAMINATION BY THE DOCTORS THERE WERE NO CONSEQUENCES AT THAT TIME.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24927760 ↗
• MalfunctionMar 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER ABLATION PROCEDURE WITH A PREFACE SHEATH AND THERE WAS BLOOD LEAKAGE IN THE HEMOSTATIC VALVE. IT WAS NOTED THAT THE HUB WAS COMPLETELY DETACHED FROM THE SHEATH. A NEW DEVICE WAS USED TO COMPLETE THE SURGERY AND THERE WAS NO PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24704370 ↗
• MalfunctionMar 26, 2026Material Separation; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PREFACE SHEATH AND THE HEMOSTATIC VALVE HAD "COLLAPSED". THIS WAS NOTED WHEN THE PACKAGING WAS OPENED. THE PROCEDURE ONLY COMMENCED ONCE A REPLACEMENT SHEATH WAS OPENED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701702 ↗
• MalfunctionMar 25, 2026Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A PREFACE SHEATH. AIR WAS CONTINUOUSLY DRAWN IN THROUGH THE SIDE PORT OF THE PREFACE SHEATH. TIMING WAS WHEN A CATHETER WAS REMOVED FROM THE PREFACE SHEATH FOR SWITCHING. NO PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691316 ↗
• InjuryFeb 5, 2026Patient Device Interaction Problem

  A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE, WHILE GOING TRANSSEPTAL WITH A PREFACE SHEATH, THE PATIENT EXPERIENCED TWO TAMPONADES FOLLOWING A HOLE THAT WAS CREATED. TAMPONADE WERE DRAINED, FOLLOWED BY OPEN THE CHEST SURGICAL INTERVENTION TO TREAT CARDIAC PERFORATION (HOLE). DURING THE REPEAT ABLATION PROCEDURE THE PATIENT EXPERIENCED TWO TAMPONADES FOLLOWING A HOLE THAT WAS CREATED DURING THE TRANSEPTAL PUNCTURE PROCEDURE THAT PRECEDED THE ABLATION STAGE. THE FIRST TAMPONADE WAS DRAINED, WHICH ALLOWED THE ABLATION PROCEDURE TO CONTINUE, AND FOLLOWING THE SECOND TAMPONADE IT WAS DECIDED TO HAVE A SURGICAL INTERVENTION TO OPEN THE CHEST TO TREAT THE TAMPONADE. THE TAMPONADE WAS TREATED SUCCESSFULLY AND PATIENT WAS RECOVERING. ACCORDING TO THE REPORT, THE TRANSEPTAL PUNCTURE WAS PERFORMED USING A BRK NEEDLE THAT WAS PASSED THROUGH THE AFORESAID INITIAL SHEATH OF THE PREFACE. THE BRK NEEDLE AND A SAFESEPT WIRE WAS ADVANCED TO CROSS THE INTERATRIAL SEPTUM FROM THE RIGHT ATRIUM TO THE LEFT ATRIUM. ACCORDING TO THE ELECTROPHYSIOLOGIST, DURING THE PUNCTURE, THE SAFESEPT WIRE THAT LED THE BRK NEEDLE (WHICH IN TURN LED THE AFORESAID BIOSENSE PREFACE SHEATH

  Patient problems: Cardiac Perforation

  MAUDE report 24274166 ↗
• MalfunctionJan 23, 2026Material Separation; Detachment of Device or Device Component; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PREFACE AND A BRIM CAP AND HEMOSTATIC VALVE SEPARATION OCCURRED. UPON OPENING THE PACKAGE, THE HEMOSTATIC VALVE COLLAPSE WAS FOUND. OPENED ANOTHER NEW ONE TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUES. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION RECEIVED INDICATING THE HEMOSTATIC VALVE WAS DISLODGED OUTSIDE THE HUB AND THE BRIM CAP HAD DETACHED FROM THE SHEATH. IT WAS DESCRIBED AS BROKEN/CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160622 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PREFACE SHEATH AND THE DILATOR WAS BROKEN. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977771 ↗

Other Biosense Webster Inc products

• THERMOCOOL SMARTTOUCH SF8 models · 6,238 reports · 1 recall
• VIZIGO3 models · 5,206 reports · 4 recalls
• QDOT MICRO7 models · 1,418 reports
• ThermoCool SmartTouch7 models · 1,163 reports
• PENTARAY NAV12 models · 842 reports · 4 recalls
• OCTARAY Mapping Catheter6 models · 407 reports
• CARTO VIZIGO2 models · 349 reports
• SOUNDSTAR6 models · 260 reports