N/A 43555Recalls & reported problems
Medtronic Ps Medical, Inc. · CATHETER 43555 PERITONEAL SMALL LUMEN · Class 2 · Implant
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 00763000028282), received between Sep 6, 2023 and Sep 6, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanics Altered” (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
- Mechanics Altered1
Patient problems
- Insufficient Information1
- 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.
MalfunctionSep 6, 2023Mechanics Altered; Mechanics Altered
ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING A HYDROCEPHALUS PROCEDURE WITH THE VALVE IN 2018 THERE WAS AN INCIDENT THAT OCCURRED AND THE IMPLEMENTATION OF THE VALVE NEEDED A SUBSTITUTION VALVE. THE MOTHER OF THE PATIENT REACHED OUT TO THE MANUFACTURER REPRESENTATIVE STATING THAT THEIR CHILD WENT THROUGH A HYDROCEPHALUS PROCEDURE AND WITH A VALVE. SINCE 2018, SEVERAL CHANGES WERE NECESSARY DUE TO TIME THE VALVES "DEPROGRAMING THEMSELVES". IN THIS CASE, IT EITHER DRAINS A LOT OR A LITTLE. EVEN AFTER MAKING ADJUSTMENTS, THE ERROR PERSISTS AND VARIOUS EXCHANGES WERE MADE, ALONGSIDE COMPLAINS AND EXPOSING THEIR CHILD TO MANY REPLACEMENT SURGERIES. THE IMPLANT STILL REMAINS IN SERVICE. THE PATIENT IS ALIVE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17690531 ↗
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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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