N/A 9040 BRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000027889), received between May 23, 2022 and Apr 20, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K831678); 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT BEFORE IMPLANTATION, THE DOCTOR TESTED THE VALVE, AND THE VALVE COULD NOT DELIVER LIQUID. THE PROCEDURE DETAILS WERE HYDROCEPHALUS. THE PROCEDURE WAS COMPLETED WITH BACKUP 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 24926312 ↗
• MalfunctionMar 31, 2026Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT/VALVE. IT WAS REPORTED THAT BEFORE IMPLANTATION, THE VALVE WAS TESTED, HOWEVER, THE VALVE COULD NOT DELIVER THE TEST LIQUID. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. THE PATIENT'S MEDICAL HISTORY WAS HYDROCEPHALUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742593 ↗
• MalfunctionMar 13, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT THE CATHETER BROKE WHEN PULLED DURING PRE-OP. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. THE PROCEDURE WAS FOR HYDROCEPHALUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590155 ↗
• MalfunctionMar 12, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT DURING PREPARATION, THE CATHETER BROKE WHEN PULLED. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. THE PROCEDURE WAS FOR HYDROCEPHALUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578373 ↗
• MalfunctionJan 21, 2026Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT THE DOCTOR USED THE SHUNT, HOWEVER, THEY MENTIONED THAT THERE WAS AN ISSUE WITH IT AS THE FLUID COULD NOT FLOW THROUGH WHEN THEY USED THE VALVE. WHEN THEY SWITCHED BACK TO THE PATIENT'S OLD VALVE, THE FLUID WAS ABLE TO FLOW. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT AFTER SPEAKING WITH THE DOCTOR, THE PATIENT'S CURRENTLY IMPLANTED CATHETER (CONNECTED TO THE OLD SHUNT) WAS BLOCKED SO THE PROCEDURE WAS TO CHANGE OUT THE OLD CATHETER AND THE OLD SHUNT TO THE NEW CATHETER AND THE NEW SHUNT. IT WAS STATED THAT THERE WAS NOTHING WRONG WITH THE PATIENT'S OLD SHUNT. THE ISSUE WAS THAT THE CEREBROSPINAL FLUID (CSF) WAS NOT DRAINING THROUGH THE NEW SHUNT. HOWEVER, THE DOCTOR MENTIONED THAT THE RESERVOIR WAS FILLING WITH FLUID DURING TESTING. AS SUCH, THE DOCTOR DECIDED NOT TO REPLACE THE OLD SHUNT WITH THE NEW FAULTY SHUNT. THE DOCTOR DID NOT SHARE ANY DETAILS REGARDING THE OLD SHUNT AS THE OLD SHUNT WAS NOT THE PROBLEM, THEREFORE, THE MANUFACTURER OF THE OLD SHUNT INCLUDING THE CURRENTLY IMPLANTED CATHETER REMAINED UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133270 ↗
• MalfunctionJul 1, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT DURING PREPARATION, WHEN THE VALVE WAS TESTED, THE DOCTOR TRIED TO PULL THE CATHETER, BUT IT WAS BROKEN OFF. 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 22370133 ↗
• MalfunctionDec 27, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT THE CATHETER BROKE OFF WHEN PULLED. THE NURSE IN CHARGE THEN USED ANOTHER DEVICE OF THE SAME MODEL, BUT THE CATHETER ALSO BROKE OFF WHEN PULLED. A THIRD ONE OF THE SAME MODEL WORKED WELL. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025823 ↗
• MalfunctionDec 27, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT THE CATHETER BROKE OFF WHEN PULLED. THE NURSE IN CHARGE THEN USED ANOTHER DEVICE OF THE SAME MODEL, BUT THE CATHETER ALSO BROKE OFF WHEN PULLED. A THIRD ONE OF THE SAME MODEL WORKED WELL. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025767 ↗
• MalfunctionNov 18, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE/SHUNT. IT WAS REPORTED THERE WAS NO BACKFLOW WHEN THE VALVE WAS TESTED FOR PATENCY PRIOR TO IMPLANTATION. NO IMPACT ON THE PATIENT AS THE SHUNT WAS REPLACED IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20705565 ↗
• MalfunctionOct 31, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT DURING PREPARATION AND TESTING THE VALVE, THE NURSE TRIED TO PULL THE TUBE, BUT IT BROKE OFF. 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 20577275 ↗
• MalfunctionSep 3, 2024Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE/SHUNT. IT WAS REPORTED THAT WHEN PRESSING THE RESERVOIR, NO WATER (CEREBROSPINAL FLUID (CSF)) WAS GOING INTO THE SHUNT, AND THUS, NO WATER PUMPING OUT. THERE WAS A PROCEDURE DELAY OF 3 MINUTES. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125509 ↗
• MalfunctionAug 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION, REGARDING A VALVE. IT WAS REPORTED, THAT WHEN INSTALLATION TESTING OCCURRED, THE VALVE WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THE PATIENT STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20027058 ↗
• MalfunctionAug 8, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT DURING TESTING BEFORE INSTALLING IN THE PATIENT, IT WAS FOUND THAT THE VALVE COULD NOT PUMP FLUID INTO THE CATHETER. THE DEVICE WAS REPLACED WITH BACKUP PRODUCT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937653 ↗
• MalfunctionAug 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT AFTER THE DEVICE WAS INSTALLED A TEST WAS CARRIED OUT, AND THE VALVE DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17493502 ↗
• MalfunctionMay 23, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DURING PROCEDURE AND BEFORE IMPLANTATION THE CATHETER WAS FOUND TO BE BROKEN. THEY USED A DIFFERENT CATHETER FOR THE PROCEDURE. THERE WAS NO REPORTED DELAY AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14476474 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K831678. 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