Axius Coronary Shunt OF-1250Recalls & reported problems
Maquet Cardiovascular LLC · Axius Coronary Shunt · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607567700604), received between May 13, 2024 and May 14, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- Hemorrhage/Blood Loss/Bleeding2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2024Break; Break
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, AXIUS CORONARY SHUNT 1.25 MM PART BROKE OFF INTO PATIENT IN THE PERICARDIUM. THE BROKEN PIECE WAS RETRIEVED USING SUCTION WITHOUT ADDITIONAL INCISIONS. A SECOND SHUNT WAS OPENED; IT BROKE INTO 2 PIECES ON THE STERILE TRAY AND WAS NOT PLACED IN PATIENT. A THIRD DEVICE WAS OPENED, AND IT DISINTEGRATED INTO PIECES ON THE STERILE TRAY. WITH NO ALTERNATIVE SHUNTS AVAILABLE, THE CORONARY WAS CLAMPED AND BLOOD FLOW WAS RESTRICTED WITH BULLDOG CLAMP. THERE WAS BLEEDING THAT WAS CAUGHT BY THE CELL SAVER. THERE WERE NO BLOOD TRANSFUSIONS. THERE WAS A PROCEDURAL DELAY DUE TO THE MULTIPLE DEVICE FAILURES. THERE WAS NO PATIENT HARM AND WAS CONSIDERED A NEAR MISS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19312629 ↗InjuryMay 13, 2024Break; Break
InjuryMay 13, 2024Break; Break
RELATED TO 1029775 AND 1029787 THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, BEFORE THEY PLACED THE AXIUS CORONARY SHUNT 1.25 MM IN THE CORONARY, THE SHUNT TIP FELL OFF INTO THE PERICARDIUM CHEST. THEY WERE ABLE TO FIND THE TIP AND RETRIEVE IT WITH THE FORCEPS, AND DID NOT USE IT. IT NEVER WENT INTO THE CORONARY. SUCTION WAS USED TO RETRIEVE THEM. THERE WAS BLEEDING THAT WAS CAUGHT BY THE CELL SAVER. NO ALTERNATIVE DEVICE WAS AVAILABLE, CLAMPED CORONARY AND RESTRICTED FLOW USING A BULLDOG CLAMP. ADDED TIME DUE TO THE MULTIPLE DEVICE FAILURES. NO HARM. THIS IS CONSIDERED A NEAR MISS.
Patient problems: Foreign Body In Patient
MAUDE report 19298416 ↗
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- Flo-Thru Intraluminal Shunt® FT-12225Synovis Life Technologies, Inc. · CLAMP, VASCULAR1 recall1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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