NA 9040 BRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169466357), received between Mar 30, 2017 and Mar 30, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2022Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT ONE MONTH AFTER IMPLANTED TO THE PATIENT IT WAS FOUND THAT SHUNT COULD NOT PUMP THE LIQUID. A NEW SHUNT WAS IMPLANTED. NO IMPACT TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13952728 ↗
• MalfunctionNov 20, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING THE PRE-OPERATION, THE SURGEON TESTED THE SHUNT, AND IT HAD WATER FLOW. WHEN THE SHUNT WAS USED ON THE PATIENT DURING THE OPERATION, THERE WAS NO WATER FLOWING THROUGH. THE SURGEON OPENED A NEW SHUNT SET, AND THE OPERATION WAS CARRIED ON WITHOUT ANY INJURIES. THIS RESULTED IN A 10 MINUTE DELAY IN 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 10878289 ↗
• MalfunctionOct 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN THE PHYSICIAN WAS TESTING THE PUMP, THE FLUID KEPT COMING AND LEAKED INSIDE THE DISTAL PART OF THE SHUNT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9221662 ↗
• MalfunctionOct 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN THE PHYSICIAN WAS TESTING THE PUMP, THE FLUID KEPT COMING AND LEAKED INSIDE THE DISTAL PART OF THE SHUNT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9221654 ↗
• MalfunctionMay 31, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PERITONEAL CATHETER BROKE DURING IMPLANT. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8660390 ↗
• MalfunctionMar 30, 2017Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PHYSICIAN COULD NOT SEE CEREBROSPINAL FLUID (CSF) FLOW INSIDE THE VALVE INTRA-OPERATIVELY WHEN THEY PALPATING THE VALVE. ACCORDING TO THE REPORT, THERE WAS FLOW OF CSF FROM THE VENTRICULAR CATHETER TO THE VALVE. REPORTEDLY, THE PHYSICIAN DETERMINED THE VALVE WAS NOT WORKING PROPERLY AND REPLACED IT WITH A DIFFERENT MANUFACTURER¿S VALVE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6447279 ↗

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