Abiomed Breethe OXY-1 System 001-3300-0011Recalls & reported problems
Breethe, Inc. · Assy, Console · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00860001797930), received between Apr 2, 2021 and Dec 21, 2021 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (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
- Application Program Freezes or Fails to Launch1
- Failure to Deliver1
- Pumping Stopped1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Respiratory Failure1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 21, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
THE COMPLAINANT REPORTED A CONSOLE FAILURE AFTER UNBOXING THE DEVICE, DURING BOOT UP (ALARMS AND FROZEN SCREEN). THERE WAS NO PATIENT INVOLVED OR IMPACTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13054126 ↗DeathApr 2, 2021Pumping Stopped; Failure to Deliver; Pumping Stopped; Failure to Deliver
A PATIENT WAS TRANSFERRED TO THE TERTIARY MEDICAL CENTER WITH A COVID + DIAGNOSIS AND IN NEED OF INTUBATION AND ESCALATED MEDICAL CARE. AN OXY-1 ECMO DEVICE WAS PLACED FOR SUPPORT AND OXYGENATION. THE SYSTEM PROVIDED V-V CANNULATION FOR 15 DAYS. DURING THE SUPPORT, ON DAY 11, THERE WERE CALLS MADE FOR TECHNICAL SUPPORT WHEN THE SCREEN WAS NOTED TO BE DARKENED, DUE THE POWER BEING MISTAKENLY SHUT OFF DUE TO A USER ERROR. THAT POWER FAILURE WAS RECTIFIED AND SUPPORT PROCEEDED ON THE SAME OXY-1 SYSTEM. ON DAY 15 THE OXY-1 ECMO HAD WHAT WAS TERMED A SYSTEM FAILURE. THE STAFF WAS THEN FORCED TO PROVIDE EMERGENCY RESUSCITATION, WHICH FAILED. THE PATIENT EXPIRED.
Patient problems: Respiratory Failure
MAUDE report 11610688 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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