Axius Coronary Shunt OF-1000Recalls & reported problems
Maquet Cardiovascular LLC · Axius Coronary Shunt · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00607567700598), received between May 10, 2021 and Jul 13, 2021 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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 18, 2026.
Most reported problems
Device problems
- No Apparent Adverse Event10
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2021No Apparent Adverse Event; No Apparent Adverse Event
MalfunctionJul 13, 2021No Apparent Adverse Event; No Apparent Adverse Event
MalfunctionJul 13, 2021No Apparent Adverse Event; No Apparent Adverse Event
MalfunctionJul 13, 2021No Apparent Adverse Event; No Apparent Adverse Event
MalfunctionJul 13, 2021No Apparent Adverse Event; No Apparent Adverse Event
MalfunctionJul 13, 2021No Apparent Adverse Event; No Apparent Adverse Event
MalfunctionJul 13, 2021No Apparent Adverse Event; No Apparent Adverse Event
MalfunctionJul 13, 2021No Apparent Adverse Event; No Apparent Adverse Event
MalfunctionJul 13, 2021No Apparent Adverse Event; No Apparent Adverse Event
MalfunctionMay 10, 2021Manufacturing, Packaging or Shipping Problem; No Apparent Adverse Event; Manufacturing, Packaging or Shipping Problem; No Apparent Adverse Event
Other Clamp, Vascular devices
- Heartstring III System 3.8MM HSK-3038Maquet Cardiovascular LLC · Clamp, Vascular1 recall4 deaths809 reports
- Heartstring III System 4.3MM HSK-3043Maquet Cardiovascular LLC · Clamp, Vascular1 recall265 reports
- TR BAND TRB24-REGTerumo Medical Corporation · CLAMP, VASCULAR284 reports
- TR BAND TRB24-REGTerumo Medical Corporation · CLAMP, VASCULAR256 reports
- HeartString III Proximal Seal HS-3045Maquet Cardiovascular LLC · Clamp, Vascular1 recall187 reports
- TR BAND TRB29-LRGTerumo Medical Corporation · CLAMP, VASCULAR67 reports
- TR BAND TRB29-LRGTerumo Medical Corporation · CLAMP, VASCULAR65 reports
- 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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