HEARTRAIL 40-6380Recalls & reported problems
Terumo Corporation · HEARTRAIL III Guiding Catheter · 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 04987350383235), received between Mar 29, 2023 and Mar 29, 2023 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DOCTOR PERFORMED AN INTERVENTIONAL PROCEDURE IN THE PROXIMAL/MID RIGHT CORONARY ARTERY (RCA) AND ENDED UP DISSECTING THE AORTA NEAR THE OSTIA OF THE RCA. A STENT WAS PLACED TO FIX THE DISSECTION. THE PATIENT WAS STABLE, AND THE PROCEDURE WAS SUCCESSFUL. THE DISSECTION HAPPENED TOWARD THE END OF THE CASE. THEY POPPED OUT OF THE OSTIUM A FEW TIMES AND DURING ONE OF THEIR LAST TIMES ENTERING, THE DOCTOR MENTIONED HE HAD DISSECTED THE AORTA RIGHT AT THE OSTIA TO THE RCA. ADDITIONAL INFORMATION WAS RECEIVED ON 08MAR2023: THE DEVICES USED WERE BALLOONS, WIRES, INTRAVASCULAR ULTRASOUND (IVUS), AND A TELESCOPING CATHETER. THE PATIENT HAD A DISSECTION THAT WAS COVERED BY A STENT.
Patient problems: Vascular Dissection
MAUDE report 16636784 ↗
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- Expo™ H74908526501Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls1 report
- Expo™ H74908526031Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls0 reports
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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