NA 22011 LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169467125), received between Nov 10, 2017 and Nov 28, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2017Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) THAT INDICATED THAT IT WAS UNKNOWN WHEN THE EVENT BEGAN OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7063326 ↗
• MalfunctionNov 10, 2017Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE VALVE WAS ¿INCOMPRESSIBLE WHEN IT WILL BE INSTALLED¿ BECAUSE LIQUID DID NOT FLOW DURING TESTING PRIOR TO IMPLANT. THE VALVE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7020690 ↗

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-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-1134-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782A. Sizes: 4 CM in length, REF (240) 27782 a. Each catheter is provided in a sealed Tyvek pla
• 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-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-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-1144-2009 · Feb 12, 2009 · Terminated
  Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27802A. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar po
• 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-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
• Z-1131-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782D. Sizes: 7 CM in length, REF (240) 27782D. Each catheter is provided in a sealed Tyvek plas
• Z-1126-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782J. Sizes: 4.5 CM in length, REF (240) 27782J. Each catheter is provided in a sealed Tyvek pl
• 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-1151-2009 · Feb 12, 2009 · Terminated
  Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27802H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar p
• Z-1149-2009 · Feb 12, 2009 · Terminated
  Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27802F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar po

…and 16 more.