NA 24003 MRecalls & reported problems
Medtronic Ps Medical, Inc. · VALVE 24003 M BUTTON MEDIUM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169466449), received between Jul 14, 2017 and Jul 14, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.
Most reported problems
Device problems
- Leak/Splash1
- Occlusion Within Device1
Patient problems
- Therapeutic Response, Decreased1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 14, 2017Leak/Splash; Occlusion Within Device; Leak/Splash; Occlusion Within Device
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE VALVE WAS NOT FUNCTIONING AND THERE WAS NO DRAINAGE OF CEREBROSPINAL FLUID. IN ADDITION, THERE WAS A SUTURE LEAK. ACCORDING TO THE REPORT, THE SHUNT WAS COMPLETELY REMOVED AND WOULD BE REPLACED WITH A DIFFERENT SHUNT AFTER TWO WEEKS. REPORTEDLY, THERE WAS NO HARM OR INJURY.
Patient problems: Therapeutic Response, Decreased
MAUDE report 6715522 ↗
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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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