FlexCath Cross™ Transseptal Solution 900301Recalls & reported problems
Medtronic, Inc. · NDL 900301 FLEXCATH CROSS AG 71CM EIFU · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000925086), received between Apr 13, 2026 and Apr 13, 2026 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Tamponade1
- Low Blood Pressure/ Hypotension1
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, IT WAS NOTED THAT BLOOD PRESSURE SIGNIFICANTLY DROPPED WHEN ATTEMPTING TRANSSEPTAL ACCESS. PERICARDIAL EFFUSION AND CARDIAC TAMPONADE WERE IDENTIFIED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE), AND PERICARDIOCENTESIS WAS PERFORMED. A DRAIN WAS PLACED AND SUTURED, AND HOSPITALIZATION WAS EXTENDED. THE CASE WAS ABORTED UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion
MAUDE report 24860034 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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