FlexCath Cross Transseptal Solution 900311Recalls & reported problems
Acutus Medical, Inc. · Class 2
Data updated Oct 16, 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 00850027837994), received between Oct 30, 2024 and Oct 30, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Advance” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance1
- Separation Problem1
Patient problems
- Hematoma1
- Retroperitoneal Hemorrhage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 30, 2024Difficult to Advance; Separation Problem; Difficult to Advance; Separation Problem
IT WAS REPORTED THAT THE PATIENT HAD A RETROPERITONEAL BLEED DISCOVERED AT THE CONCLUSION OF THE CASE. THE PHYSICIAN REPORTED THE FLEXCATH CROSS CAME UNSNAPPED AS IT WAS ADVANCED WITH THE FLEXCATH CONTOUR UP THE VASCULATURE. THE PHYSICIAN WAS NOT AWARE IT HAD HAPPENED UNTIL THE DEVICE HAD ALREADY CREEPED UP LATERALLY AND NOT OVER THE WIRE. AT THAT TIME, THE PHYSICIAN BECAME AWARE THAT THE GUIDEWIRE (INCLUDED IN THE PACKAGING OF THE FLEXCATH CROSS) HAD KINKED. A NEW FLEXCATH CROSS WAS OFFERED AND DECLINED, BUT THE WIRE WAS REPLACED WITH A COOK AMPLATZ 0.032J. TRANSEPTAL ACCESS WAS OBTAINED VIA THE FLEXCATH CROSS/ FLEXCATH CONTOUR WITHOUT ISSUE. CRYOABLATION OF THE PULMONARY VEINS WAS COMPLETED SUCCESSFULLY, HOWEVER LABILE BLOOD PRESSURES WERE NOTED THROUGHOUT THE CASE. THE RETROPERITONEAL BLEED WAS DISCOVERED AFTER THE SHEATHS HAD BEEN PULLED AND A SAFE SEAL CLOSURE DEVICE DEPLOYED. NO INTERVENTIONS WERE REQUIRED AND THE BLEED RESOLVED ON ITS OWN. HOWEVER, THE PHYSICIAN NOTED A SIGNIFICANT GROIN HEMATOMA. THE PATIENT'S HOSPITALIZATION WAS EXTENDED FOR MONITORING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Hematoma; Retroperitoneal Hemorrhage
MAUDE report 20570877 ↗
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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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