FORESIGHT OXIMETER CABLE HEMFSM10Recalls & reported problems
Edwards Lifesciences LLC · FORESIGHT OXIMETER CABLE · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103210927), received between Nov 12, 2025 and Nov 12, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Aug 11, 2026Open, Classified
Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
Z-3250-2026 · Root cause: Labeling mix-ups · FDA record ↗
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
AS REPORTED DURING USE IN A PATIENT THIS FORESIGHT ELITE TISSUE OXIMETER MODULE INDICATED AN ELEVATION IN STO2 VALUES. THE EXPECTED VALUES WERE AROUND 70%, BUT THE DISPLAYED VALUES EXCEEDED 90%. NO TREATMENT WAS ADMINISTERED TO THE PATIENT BASED ON THE INACCURATE VALUES. WHEN THIS FORESIGHT ELITE TISSUE OXIMETER MODULE WAS REPLACED, THE ISSUE WAS RESOLVED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23535242 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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