NA 42544Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00643169466913), received between Dec 15, 2016 and Nov 11, 2021 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2021Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT WAREHOUSE ENVIRONMENT WERE ALL IN COMPLIANCE WITH THE RULES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12797449 ↗
• MalfunctionFeb 1, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE VALVE WAS UNABLE TO EXHAUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11258845 ↗
• MalfunctionJul 24, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE VALVE WOULD NOT PUMP WATER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10322117 ↗
• MalfunctionJun 1, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE SHUNT COULDN'T AIR EXHAUST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10105241 ↗
• MalfunctionOct 16, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PRE-OPERATIVE TEST WAS FOUND TO BE ABNORMAL. IT WAS STATED THAT THE WATER COULD NOT ENTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9199545 ↗
• MalfunctionDec 27, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE PHYSICIAN FOUND THERE WAS A ¿PRESSURE PROBLEM.¿ THE VALVE WAS TO BE REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8200292 ↗
• InjuryAug 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS STATED THE PRODUCT HAD BEEN IMPLANTED AND THE DRAINAGE WAS NOT SMOOTH. AFTER PRESSING THE VALVE MANY TIMES, THE VALVE WOULD LOSE FUNCTION AND THE DEVICE WAS FILLED WITH AIR. THE PRODUCT WAS REPLACED AND THE PATIENT¿S STATUS WAS LISTED AS ALIVE ¿ NO INJURY..

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7796897 ↗
• MalfunctionAug 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE DEVICE WAS ABSORBABLE BUT NOT DRAINABLE. IT WAS STATED IT WAS BLOCKED AT THE DISTAL DRAIN. THE DEVICE WAS NEVER IMPLANTED, AND THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7768342 ↗
• MalfunctionMay 21, 2018Device Operates Differently Than Expected; Appropriate Device Problem Term/Code Not Available; Device Operates Differently Than Expected; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE VALVE ¿DID NOT FUNCTION¿ DURING THE PROCEDURE. THE VALVE WAS NEVER IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7529708 ↗
• MalfunctionJan 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE VALVE COULD NOT PUMP WATER PRIOR TO USE. THE VALVE WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7216827 ↗
• MalfunctionJul 27, 2017Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE VALVE DID NOT APPEAR TO BE WORKING WHEN TESTED PRIOR TO IMPLANT. ACCORDING TO THE REPORT, THE VALVE WAS DRAINING WHEN PRIMED, BUT NOT SPONTANEOUSLY. IT WAS NOTED THE PATIENT HAD HIGH PRESSURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6747066 ↗
• MalfunctionJul 21, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE SURGEON COMPLAINED THAT THE PATIENT HAD HIGH INTRACRANIAL PRESSURE, BUT WHEN THE VALVE WAS CONNECTED, THE CEREBROSPINAL FLUID (CSF) WOULD NOT FLOW OUT OF THE DISTAL END OF THE CATHETER. ACCORDING TO THE REPORT, THE SURGEON PRIMED THE VALVE WITH RINGERS PRIOR TO CONNECTING IT UP TO THE DISTAL CATHETER. ONCE THE VALVE WAS CONNECTED TO THE VENTRICULAR CATHETER, IT WOULD NOT FLOW CSF FREELY EVEN WHEN THE CSF WAS AT HIGH PRESSURE. THE RESERVOIR WAS PUMPED DURING THE PROCEDURE TO TRY AND GET DRAINAGE COMMENCED. REPORTEDLY, ANOTHER DEVICE WAS USED AS A REPLACEMENT. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6731776 ↗
• MalfunctionJul 21, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE SURGEON COMPLAINED THAT THE PATIENT HAD HIGH INTRACRANIAL PRESSURE, BUT WHEN THE VALVE WAS CONNECTED, THE CEREBROSPINAL FLUID (CSF) WOULD NOT FLOW OUT OF THE DISTAL END OF THE CATHETER. ACCORDING TO THE REPORT, THE SURGEON PRIMED THE VALVE WITH RINGERS PRIOR TO CONNECTING IT UP TO THE DISTAL CATHETER. ONCE THE VALVE WAS CONNECTED TO THE VENTRICULAR CATHETER, IT WOULD NOT FLOW CSF FREELY EVEN WHEN THE CSF WAS AT HIGH PRESSURE. THE RESERVOIR WAS PUMPED DURING THE PROCEDURE TO TRY AND GET DRAINAGE COMMENCED. REPORTEDLY, ANOTHER DEVICE WAS USED AS A REPLACEMENT. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6731770 ↗
• MalfunctionApr 28, 2017Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE RESERVOIR'S FLEXIBILITY WAS FOUND TO BE POOR AT THE PRE-OPERATION TEST. ACCORDING TO THE REPORT, THE RESERVOIR COULD NOT BE EASILY FILLED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6529360 ↗
• MalfunctionFeb 8, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WOULD NOT DRAIN INTRA-OPERATIVELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6313270 ↗
• MalfunctionDec 15, 2016Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING TESTING PRIOR TO IMPLANTATION, THE PHYSICIAN ATTEMPTED TO PUMP THE VALVE INSIDE SALINE SOLUTION, BUT NOTICED THERE WAS NO FLUID FLOW. ACCORDING TO THE REPORT, THE VALVE WAS REPLACED WITH A NEW VALVE AND THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATION. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6179623 ↗

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