N/A 42534Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000027667), received between Aug 1, 2022 and Dec 17, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K841442); they may or may not involve this specific model.

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE VALVE COULD NOT PUMP CEREBROSPINAL FLUID INTO THE VALVE. THE VALVE WAS CHANGED TO A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828368 ↗
• MalfunctionMar 20, 2025Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A HYDROCEPHALUS VALVE. IT WAS REPORTED THAT THE VALVE COULD NOT PRIME NORMAL SALINE IN THE VALVE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652455 ↗
• MalfunctionMay 23, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT WHEN TESTING THE VALVE, NO SALINE WOULD STAY WITHIN THE VALVE, EVEN WITH THE CATHETER CONNECTED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THERE WAS A PROCEDURE DELAY OF 10 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19380778 ↗
• MalfunctionMar 8, 2024Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED REGARDING A VALVE. IT WAS REPORTED THAT DURING THE PROCEDURE AFTER THE SHUNT WAS IMPLANTED, IT WAS NOT WORKING AS THERE WAS NO CEREBROSPINAL FLUID (CSF) FLOW. ANOTHER VALVE WAS USED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865687 ↗
• MalfunctionAug 1, 2022Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED ON A PATIENT. IT WAS REPORTED THAT WHEN THE CATHETER WAS USED THERE WAS NO CEREBROSPINAL FLUID (CSF). THE CATHETER WAS REPLACED AND THE LIQUID CAME OUT. THERE WAS A REPORTED DELAY OF 20 MINUTES. NO PARTS WERE CONFIRMED TO REMAIN IN THE BODY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15139514 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K841442. One submission often covers many models, so check the product and lot details in each record.

• Z-1117-2021 · Jan 11, 2021 · Open, Classified
  Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY
• Z-0397-2014 · Nov 18, 2013 · Terminated
  CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Reg