HemoSphere Alta ALTASR1Recalls & reported problems
Edwards Lifesciences LLC · HemoSphere Alta advanced monitor (Smart Recovery) · Class 2
All models of HemoSphere Alta (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103217964), received between Nov 26, 2025 and Feb 12, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement2
- Incorrect, Inadequate or Imprecise Result or Readings2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2026Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT, DURING USE, THE HEMOSPHERE ALTA MONITOR EXPERIENCED SIGNIFICANT MEAN ARTERIAL PRESSURE (MAP) VARIABILITY WHEN USING CLEARSIGHT. SPECIFICALLY, ARTERIAL LINE CORRELATION DRIFTING BY 20 TO 40 MMHG. IT WAS ALSO NOTED THAT THE SUSPECT DEVICE EXPERIENCED FAULT: CLEARSIGHT SYSTEM AIR SUPPLY ERROR AND INSUFFICIENT PRESSURE BUILD UP. THERE ARE NO ALLEGATIONS OF PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24328911 ↗MalfunctionNov 26, 2025Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRIOR TO USE, THE HEMOSPHERE ALTA SYSTEM WITH CLEARSIGHT DISPLAYED A SUBSYSTEM FAILURE ALERT. THE END USER RESTARTED THE DEVICE AND CLEARED THE ALERT; HOWEVER, SUBSEQUENT MEASUREMENTS SHOWED VARIATIONS IN BLOOD PRESSURE (BP) AND PULSE RATE (PR). THE ISSUE COULD NOT BE RESOLVED EVEN AFTER REPLACING THE PC2K MODULE. ADDITIONAL FOLLOW-UP EFFORTS HAVE FOCUSED ON DETERMINING PATIENT INVOLVEMENT AND WHETHER ANY INJURY OR HARM OCCURRED AS A RESULT OF THE REPORTED EVENT. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23659549 ↗
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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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