FlexCath Cross Transseptal Solution 900304-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850027837826), received between Jan 17, 2024 and May 14, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Slipped” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A CRYO ABLATION PROCEDURE, THE PATIENT EXPERIENCED SEVERAL ADVERSE EVENTS. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PAIN AND SHORTNESS OF BREATH. THE CHEST PAIN WAS LOCATED IN THE MIDDLE OF THE CHEST. POST-ABLATION PERICARDITIS WAS IDENTIFIED. DIAGNOSTIC TESTS INCLUDED A BLOOD TEST SHOWING MILD LEUKOCYTOSIS AND MILD THROMBOCYTOPENIA, AN ELECTROCARDIOGRAM INDICATING NORMAL SINUS RHYTHM, AN ECHOCARDIOGRAM WITH AN EJECTION FRACTION OF 64% AND NO PERICARDIAL EFFUSION, AND AN X-RAY SHOWING NO ACUTE PROCESS. INTERVENTIONS INCLUDED ADMINISTRATION OF OPIOID, A NON-STEROIDAL ANTI-INFLAMMATORY DRUG, AND A MINERAL SUPPLEMENT. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION AND SUBSEQUENTLY RECOVERED. THE OUTCOME OF THIS CASE IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. 2025-05-09: IT WAS LATER REPORTED THAT THE CASE WAS COMPLETED WITH CRYO.

  Patient problems: Chest Pain; Dyspnea; Pericarditis

  MAUDE report 22022349 ↗
• InjuryMay 17, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PHYSICIAN ADVANCED THE FLEXCATH CROSS SYSTEM INTO THE SUPERIOR VENA CAVA SVC, BUT HAD TROUBLE POSITIONING ON SEPTUM DUE TO ATRIAL PACING LEAD. THE PHYSICIAN OBTAINED TRANSSEPTAL ACCESS WITH VERSACROSS WIRE, BUT WAS UNABLE TO GET FLEXCATH SHEATH ACROSS THE SEPTUM. A DROP IN PATIENT'S BLOOD PRESSURE WAS NOTED. THE PHYSICIAN THEN UTILIZED INTRACARDIAC ECHOCARDIOGRAPHY ICE TO VISUALIZE AN EFFUSION AROUND THE PATIENT'S HEART. A PERICARDIOCENTESIS WAS PERFORMED AND 350CC OF BLOOD WAS REMOVED. THE CASE WAS ABORTED. THE PATIENT WAS STABILIZED AND ADMITTED TO THE ICU.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 19347047 ↗
• InjuryJan 17, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT PERICARDIAL EFFUSION WAS OBSERVED AFTER THE TRANSSEPTAL PUNCTURE WAS PERFORMED DURING A CRYO ABLATION PROCEDURE. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND WAS GIVEN HEPARIN BEFORE THE TRANSSEPTAL PUNCTURE. THE PERICARDIAL EFFUSION WAS NOTED JUST AFTER THE COMPLETION OF THE TRANSSEPTAL PUNCTURE. A PERICARDIAL TAP WAS PERFORMED TO ADDRESS THE ISSUE AND THE ANTICOAGULANT (HEPARIN) WAS REVERSED. THE CASE WAS ABORTED AND THE PATIENT WAS MOVED TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. THE PATIENT'S HOSPITALIZATION WAS EXTENDED. THE PATIENT RESPONDED WELL TO THE PERICARDIAL TAP AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 18531263 ↗