Diversatek Healthcare ZAI-BS-01Recalls & reported problems
Diversatek Healthcare, Inc. · Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with LES Locator, Locator Port 6cm · 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 00816734022252), received between Oct 23, 2024 and Oct 23, 2024 — 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.
MalfunctionOct 23, 2024No Apparent Adverse Event; No Apparent Adverse Event
PER USER FACILITY REPORT (B)(4): DESCRIBE THE EVENT OR PROBLEM: PATIENT WAS HAVING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) AND PLACEMENT OF 24-HOUR IMPEDANCE PH CATHETER. WHEN CALIBRATING THE CATHETER PRIOR TO PLACEMENT, AN IMPEDANCE ERROR MESSAGE APPEARED ON THE RECORDER. TRIED MULTIPLE CATHETERS AND DIFFERENT RECORDERS. ALL HAD THE SAME ERROR MESSAGE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : EGD. WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) ; DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; DEVICE WAS HARD TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20518166 ↗
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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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