N/A 22011 MRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000028466), received between Nov 18, 2021 and Apr 20, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (5 reports).

31 other recalls cover devices cleared under the same FDA submission (K792007); 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 10 most recent of 10 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 WHEN TESTED BEFORE IMPLANTING, THE DOCTOR FOUND THAT THE VALVE COULD NOT DELIVER LIQUID. 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 24928043 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT 2 DAYS AFTER IMPLANTATION, IRRITATION HAPPENED. THEREFORE, THE DOCTOR REPLACED THE PRODUCT TO ANOTHER ONE OF THE SAME MODEL. THE PROCEDURE DETAILS WERE HYDROCEPHALUS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Tissue Irritation

  MAUDE report 24926249 ↗
• MalfunctionJul 7, 2025Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT/VALVE. IT WAS REPORTED THAT DURING PREPARATION, THE VALVE WAS TESTED, BUT LIQUID COULD NOT FLOW OUT FROM THE VALVE. THE HEALTHCARE PROFESSIONAL (HCP) TRIED A SECOND VALVE, BUT IT ALSO HAD THE SAME PROBLEM. THE PROCEDURE CONTINUED BY USING A CONTOURED REGULAR, MEDIUM PRESSURE SHUNT. THE DETAILS OF THE PROCEDURE WAS POST SC HYDROCEPHALUS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413038 ↗
• MalfunctionJul 7, 2025Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT/VALVE. IT WAS REPORTED THAT DURING PREPARATION, THE VALVE WAS TESTED, BUT LIQUID COULD NOT FLOW OUT FROM THE VALVE. THE HEALTHCARE PROFESSIONAL (HCP) TRIED A SECOND VALVE, BUT IT ALSO HAD THE SAME PROBLEM. THE PROCEDURE CONTINUED BY USING A CONTOURED REGULAR, MEDIUM PRESSURE SHUNT. THE DETAILS OF THE PROCEDURE WAS POST SC HYDROCEPHALUS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412999 ↗
• MalfunctionJun 10, 2025Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT DURING PREPARATION, THE CHAMBER WAS TESTED, BUT IT WAS BLOCKED. THEREFORE, IT WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE REPORTED EVENT RESULTED IN A PROCEDURE DELAY. THE PATIENT'S STATUS WAS ALIVE-NO INJURY. THE PATIENT'S MEDICAL HISTORY WAS POST SC WITH HYDROCEPHALUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178142 ↗
• MalfunctionNov 3, 2023Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT THE LIQUID DID NOT COME OUT WHEN THE VALVE WAS TESTED WITH WATER. 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 18066697 ↗
• MalfunctionFeb 6, 2023Break; Fracture; Mechanical Jam; Break; Fracture; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT USED DURING A PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, "THERE WAS STUCK ON THE CATHETER." IT WAS NOTED THAT THE PRODUCT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16305383 ↗
• MalfunctionNov 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15734858 ↗
• MalfunctionNov 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THE VALVE HAD NO CONTACT WITH THE PATIENT, THE DOCTOR DID THE TEST BEFORE PUTTING IT IN AND IT DID NOT WORK. SO NO ENVIRONMENTAL/EX TERNAL/PATIENT FACTORS LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12847051 ↗
• MalfunctionNov 18, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE CATHETER WAS IN PLACE; HOWEVER, FLUID DID NOT COME OUT. THE HEALTHCARE PROFESSIONAL PRESSED SLOW IN THE VALVE, BUT FLUID STILL DID NOT COME OUT. THE HEALTHCARE PROFESSIONAL CHANGED TO ANOTHER SHUNT, AND THE PROCEDURE WAS SUCCESSFULLY. IT WAS NOTED THIS RESULTED IN A PROCEDURE DELAY OF AN UNKNOWN TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12836853 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K792007. 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
• Z-1127-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782H. Sizes: 11 CM in length, REF (240) 27782H. Each catheter is provided in a sealed Tyvek pla
• Z-1138-2009 · Feb 12, 2009 · Terminated
  Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27708D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The
• Z-1142-2009 · Feb 12, 2009 · Terminated
  Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27708H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The
• Z-1140-2009 · Feb 12, 2009 · Terminated
  Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27708F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The
• Z-1125-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782K. Sizes:5.5CM in length, REF (240) 27782K. Each catheter is provided in a sealed Tyvek plas
• Z-1129-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782F. Sizes: 9 CM in length, REF (240) 27782F. Each catheter is provided in a sealed Tyvek plas
• Z-1147-2009 · Feb 12, 2009 · Terminated
  Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27802D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar po
• Z-1124-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782L. Sizes: 3 CM in length, REF (240) 27782L. Each catheter is provided in a sealed Tyvek plas
• Z-1139-2009 · Feb 12, 2009 · Terminated
  Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27708E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The
• Z-1128-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782G. Sizes 10cm in length, REF (240) 27782G. Each catheter is provided in a sealed Tyvek plast
• Z-1133-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782B. Sizes: 5 CM in length, REF (240) 27782B. Each catheter is provided in a sealed Tyvek plas
• Z-1145-2009 · Feb 12, 2009 · Terminated
  Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27802B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar po
• Z-1143-2009 · Feb 12, 2009 · Terminated
  Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27708J Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The

…and 16 more.