N/A 42544Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000028398), received between Jan 7, 2022 and Apr 28, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT DURING IMPLANTATION, THE CATHETERS WERE PULLED, BUT IT WAS BROKEN OFF. ALL THE ITEMS IN THE SYSTEM (1 VALVE, 2 CATHETERS) WERE DISCARDED BY THE HOSPITAL. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016008 ↗
• 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 23827650 ↗
• MalfunctionSep 12, 2025Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT BEFORE THE VALVE WAS IMPLANTED IN THE PATIENT, THE DOCTOR TRIED THE VALVE, BUT THE LIQUID DID NOT COME OUT (VALVE BLOCKED). THE DOCTOR THEN USED A BACK UP PRODUCT TO COMPLETE THE PROCEDURE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037248 ↗
• MalfunctionAug 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DOCTOR DETERMINED THAT THE VALVE WAS DEFECTIVE/NOT WORKING. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877852 ↗
• MalfunctionAug 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE FIRST VALVE WAS PLACED IN THE PATIENT, HOWEVER, IT WAS NOT WORKING SO A NEW ONE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790423 ↗
• InjuryMay 2, 2025Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE SURGEON STATED THE VALVE WAS FAULTY, AND THEY SUSPECTED IT TO BE OCCLUDED/BLOCKED. THE VALVE WAS EXPLANTED AND REVISED WHERE A NEW VALVE WAS INSERTED. THE PATIENT WAS CURRENTLY RECOVERING, AND THEIR STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949317 ↗
• MalfunctionMar 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT DURING PROCEDURE THERE WAS A LEAK. THE PROCEDURE WAS COMPLETED USING BACKUP PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 16502260 ↗
• MalfunctionAug 10, 2022Break; Fracture; Infusion or Flow Problem; Break; Fracture; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT SYSTEM. IT WAS REPORTED THAT DURING THE FLOW TEST THERE WAS A TORN PART IN THE CHAMBER AND IT CLOSED THE FLOW OFF LIQUID. THE PROCEDURE WAS COMPLETED USING BACK UP PRODUCTS. IT WAS REPORTED THAT THE PRODUCT DID HAVE CONTACT WITH THE PATIENT. THERE WAS ON ADVERSE EVER ASSOCIATED WITH THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202093 ↗
• MalfunctionJan 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A BROKEN IMPLANT. IT WAS REPORTED THAT THERE WAS A DEFECTIVE SHUNT, THE HOSE WAS BROKEN WHEN IMPLANTED TO THE PATIENT. THE DAMAGED PARTS WERE REPLACE WITH BACKUP PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13194499 ↗

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