PREFACE 301805MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10846835000061), received between Dec 14, 2020 and Sep 4, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionSep 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A PREFACE AND WHEN PULLING OUT THE CATHETER, THE PHYSICIAN NOTICED THE SEAL OF THE SHEATH COMING OUT WITH THE CATHETER. THE SEALING WITH THE CATHETER PROXIMAL FELL OFF. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 07-AUG-2024. PULLING OUT THE CATHETER, THE PHYSICIAN NOTICED THE SEAL OF THE SHEATH COMING OUT WITH THE CATHETER. THIS ISSUE IS NOT RELATED TO THE CATHETER TOUCHING A NON-STERILE SURFACE. THE CATHETER WAS USED ON THE PATIENT. IT WAS USED FOR THE PROCEDURE AND THE ISSUE WAS NOTICED WHEN PULLING OUT THE CATHETER. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF ADDITIONAL INFORMATION CLARIFYING WHEN ¿PULLING OUT THE CATHETER, THE PHYSICIAN NOTICED THE SEAL OF THE SHEATH COMING OUT WITH THE CATHETER¿ ON 07-AUG-2024 AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE ISSUE IS 07-AUG-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20136124 ↗
• MalfunctionApr 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND THE CAP CAME OFF ISSUE OCCURRED. THE CAP CAME OFF THE PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE DURING THE PROCEDURE. THEY REPLACED THE PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND THE PROCEDURE CONTINUED WITHOUT FURTHER ISSUES. THE NGEN GENERATOR WAS USED FOR ABLATION. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE SHEATH WAS BEING USED ON A PATIENT. THERE WAS NO AIR THAT ENTERED THE PATIENT AND/OR BLOOD LOSS FROM THE SHEATH HUB. THERE WAS NO PATIENT CONSEQUENCE OR TREATMENT NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105278 ↗
• MalfunctionDec 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT CARDIAC ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE WHERE BRIM CAP DETACHMENT OCCURRED. IT WAS REPORTED THAT THE CARTO 3 SYSTEM WAS DISPLAYING NOISE ON THE DISTAL ECG OF THE CATHETER WHEN CONNECTED TO THE PIU. THE CALLER STATED THAT THE NOISE WAS ALSO SEEN ON THE RECORDING SYSTEM. THE CALLER REPLACED THE CABLE WITHOUT RESOLUTION. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED. IT WAS ALSO REPORTED THAT WHEN PULLING THE CATHETER OUT OF THE PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE THAT THE VALVE CAP CAME OFF THE END OF THE SHEATH. THE CALLER REPLACED THE SHEATH AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED. THERE WAS NO REPORT OF PATIENT CONSEQUENCE. THE HEMOSTATIC VALVE DID NOT BREAK. THE SHEATH WAS BEING USED ON THE PATIENT AT THE TIME OF THE EVENT. NO AIR ENTERED THE PATIENT¿S BODY. THE HEMODYNAMICS WAS NOT COMPROMISED, ONLY MINIMAL AMOUNT OF BLOOD LEAKED (8-10ML). NO INTERVENTION WAS REQUIRED. A GUIDEWIRE WAS INSERTED AND PROMPTLY EXCHANGED FOR ANOTHER SHEATH. NOISE ON THE ECG IS NOT MDR-REPORTABLE. BRIM CAP DETACHMENT IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11001384 ↗