Diversatek Healthcare PHN15Recalls & reported problems
Diversatek Healthcare, Inc. · Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 15cm Spacing · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816734022061), received between May 13, 2026 and May 13, 2026 — classified as 1 malfunction.
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
- No Apparent Adverse Event1
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.
MalfunctionMay 13, 2026No Apparent Adverse Event
PER MAUDE ADVERSE EVENT REPORT NUMBER(B)(4): IT WAS REPORTED THAT THE 24 HR PH PROBE WOULD NOT CALIBRATE, CHECKED ALL CONNECTIONS, THEN RETRIED CALIBRATION, STILL WOULD NOT CALIBRATE, THEN CHANGED PH SOLUTIONS AGAIN AND THEN TRIED AGAIN, STILL WOULD NOT CALIBRATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND IT WAS CONFIRMED BY FURTHER FOLLOW UP TO THE REPORTER THAT THERE WAS NO PATIENT HARM. DIVERSATEK HEALTHCARE ACKNOWLEDGES RECEIPT OF THE FDA MEDWATCH REPORT REFERENCED ABOVE. UPON RECEIPT, THE REPORT WAS EVALUATED IN ACCORDANCE WITH OUR INTERNAL PROCEDURES AND 21 CFR PART 803.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162623 ↗
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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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