CardiaGuide™ 00884450504789Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450504789), received between Aug 9, 2022 and May 15, 2024 — classified as 4 injuries.

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 18, 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.

• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT POST TRANSEPTAL PUNCTURE FOR A PULMONARY VEIN ISOLATION [PVI] PROCEDURE, A TRANSESOPHAGEAL ECHO [TEE] WAS ORDERED TO DETERMINE THE CAUSE OF BLOOD PRESSURE CHANGES IN THE PATIENT. THE TEE ACCURATELY IDENTIFIED PERICARDIAL EFFUSION/FLUID COLLECTING WITHIN THE PATIENT'S PERICARDIAL SAC. A PERICARDIOCENTESIS WAS SUCCESSFULLY PERFORMED TO PREVENT CARDIAC TAMPONADE FOR THIS PATIENT. THE PHYSICIAN STATES THAT CARDIAC TAMPONADE IS A KNOWN COMPLICATION OF TRANSSEPTAL PUNCTURE PROCEDURE WHICH WAS A DIFFICULT PROCEDURE FOR THIS PATIENT. NO ADDITIONAL PATIENT COMPLICATIONS TO REPORT. THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19321647 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A SECONDARY A-FIB ABLATION PROCEDURE, THE NEEDLE PIERCED THE TRANSEPTAL SHEATH BEFORE THE TRANSEPTAL PUNCTURE COULD BE COMPLETED. THE SHEATH WAS SUCCESSFULLY EXCHANGED. APPROXIMATELY 60 MIN INTO THE PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED BY THE ATTENDING PHYSICIAN. AN EMERGENT PERICARDIOCENTESIS WAS PERFORMED BUT THE PATIENT'S EFFUSION CONTINUED. THE PATIENT REQUIRED SURGICAL INTERVENTION TO PREVENT CARDIAC TAMPONADE. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: Cardiac Tamponade

  MAUDE report 15685550 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTS DURING A TRANSSEPTAL PUNCTURE PROCEDURE THE AORTA WAS PERFORATED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 15596610 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT A PATIENT SUFFERED A PERICARDIAL EFFUSION DURING A EP PROCEDURE WHILE MAPPING THE LEFT ATRIUM. THE PATIENT'S BP PRESSURE DROPPED. AN ICE CATHETER AND ECHO STUDY WAS USED TO CONFIRM THE EFFUSION. THE PHYSICIAN STATES THAT POSSIBLE PERFORATION OF THE LEFT ATRIAL APPENDAGE IS SUSPECT. A PERICARDIOCENTESIS PROCEDURE WAS SUCCESSFULLY PERFORMED BY THE CLINICAL STAFF SUCCESSFULLY REMOVING THE FLUID FROM WITHIN THE PATIENT'S PERICARDIAL SPACE. THE PRIMARY PROCEDURE WAS TEMPORARILY ABORTED. THE PATIENT IS STABLE AND WAS TRANSFERRED TO THE UNIT FOR OVERNIGHT OBSERVATION. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15196289 ↗