FlexCath Cross Transseptal Solution 900308-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850027837901), received between Jun 1, 2024 and Oct 22, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TO PLACE A LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE FROM ANOTHER MANUFACTURER, THE DILATOR/TRANSSEPTAL NEEDLE AND SHEATH WERE ADVANCED INTO THE EXTERNAL ILIAC VEIN. IT WAS FURTHER REPORTED THAT PATIENT'S BLOOD PRESSURE DROPPED, AND AN EXTERNAL ILIAC VEIN PERFORATION OCCURRED. A BALLOON ANGIOPLASTY WAS PERFORMED TO STOP THE BLEEDING. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE CASE WAS ABORTED. A COMPUTERIZED TOMOGRAPHY (CT) WAS PERFORMED AND CONFIRMED THAT THE BLEEDING HAD STOPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PER FOLLOW UP FROM THE REPRESENTATIVE THERE WERE NO COMPLICATIONS OR OBSERVATIONS NOTED PRIOR TO THE EVENT. NO DEVICE MALFUNCTION OR ISSUE WAS REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 20510372 ↗
• InjuryJun 1, 2024Unintended Movement; Insufficient Device Problem Information; Unintended Movement; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, IT WAS DIFFICULT TO CROSS THE SEPTUM USING THE INTEGRATED NEEDLE/DILATOR. TWO ATTEMPTS WERE MADE TO CROSS THE SEPTUM, AND THEN THE PHYSICIAN SWITCHED TO USING RADIOFREQUENCY (RF) INSTEAD, WITHOUT RESOLUTION. THE SHEATH AND THE INTEGRATED NEEDLE/DILATOR SYSTEM WERE REMOVED. THE 0.032 AMPLATZ GUIDEWIRE REMAINED IN AND WHEN ADVANCED, IT ENTERED INTO THE LEFT ATRIUM. AFTER THE FIRST RF ATTEMPT THE PATIENT STARTED TO EXCESSIVELY COUGH AND COMPLAINED OF SHORTNESS OF BREATH. THE GUIDEWIRE WAS REMOVED AND ICE IMAGING SHOWED A SMALL EFFUSION. PROTAMINE WAS ADMINISTERED. THE PATIENT WAS STABLE WITH NORMAL VITALS WHEN LEAVING THE OPERATING ROOM. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 19442198 ↗