NA 22011 M (UDI 00643169467149)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169467149), received between Nov 28, 2017 and Nov 11, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS THAT THE SHUNT FAILED TO KEEP NECESSARY PRESSURE. THE SHUNT WAS IMPLANTED ON THE RIGHT SIDE IN THE KOCHER'S POINT FOR COMBINATION DYSFUNCTION COMPLEX, OCCLUSIVE HYDROCEPHALUS. THE SHUNT WAS EXPLANTED AND REPLACED WITH ANOTHER DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9305434 ↗
• MalfunctionFeb 15, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHEN PLACING THE CATHETERS AND CONNECTING THE VALVE, THERE WAS NO DISTAL FLOW OF CEREBROSPINAL FLUID. WHEN CHECKING THE SYSTEM, FLOW IN THE PROXIMAL DIRECTION WAS FOUND, SO ANOTHER VALVE WAS USED. THE CATHETERS REMAINED IMPLANTED AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8346280 ↗
• MalfunctionDec 6, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHILE TESTING THE VALVE DURING THE PROCEDURE, THE PHYSICIAN THOUGHT THAT THE ARROW INDICATING THE FLOW DIRECTION WAS UPSIDE DOWN, HOWEVER IT WAS CONFIRMED TO BE POINTING IN THE RIGHT DIRECTION. THERE WAS DIFFICULTY IN DRAINING THE LIQUID. WHEN PLACING THE SYSTEM AND CONNECTING THE VALVE, IT WAS CONFIRMED THAT THERE WAS NO CEREBROSPINAL FLUID DRAINAGE AFTER SEVERAL ATTEMPTS AND EVEN CHANGING THE DIRECTION OF THE RESERVOIR. IT WAS THOUGHT THE SLOW DRAINAGE CLAIM COULD BE DUE TO EXCESSIVE VENTRICLE DRAINAGE PRIOR TO CONNECTING THE VALVE. THE VALVE WAS REPLACED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8137856 ↗
• MalfunctionNov 28, 2017Inaccurate Flow Rate; Inaccurate Flow Rate

  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 7063323 ↗

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-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-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-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-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-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-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-1141-2009 · Feb 12, 2009 · Terminated
  Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9CM, Ref 27708G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The s
• 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
• Z-1132-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782C. Sizes: 6 CM in length, REF (240) 27782C. Each catheter is provided in a sealed Tyvek plas
• Z-1148-2009 · Feb 12, 2009 · Terminated
  Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27802E. 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
• Z-1152-2009 · Feb 12, 2009 · Terminated
  Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27802J. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar p
• 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

…and 16 more.