FlexCath Cross Transseptal Solution 900301-003Recalls & reported problems
Acutus Medical, Inc. · FlexCath Cross Transseptal Solution– AG 71 cm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850027837765), received between Apr 30, 2024 and Apr 30, 2024 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2024
ELDERLY MALE WITH HISTORY OF PAROXYSMAL ATRIAL FIBRILLATION. PROCEDURE: ELECTROPHYSIOLOGY STUDY WITH ABLATION. THE NEEDLE OF THE MEDTRONIC FLEXCATH CROSS STICKS PAST THE END OF THE SHEATH. IT DOES NOT RETRACT INTO THE SHEATH. PRODUCT NOT USED ON PATIENT. NO KNOWN HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19212337 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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