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NA 22011 M (UDI 00613994803757)Recalls & reported problems

Medtronic Ps Medical, Inc. · SHUNT 22011 M INTL ONLY ULTRA SM MED · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994803757), received between Jan 18, 2017 and Jan 18, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Occlusion Within Device” (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

Device problems

  • Occlusion Within Device1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 18, 2017Occlusion Within Device; Occlusion Within Device

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THERE WAS NO DRAINAGE WITH THE VALVE INTRA-OPERATIVELY. ACCORDING TO THE REPORT, THE VALVE WAS REPLACED TO COMPLETE THE PROCEDURE AND THERE WAS NO INJURY TO THE PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6261124 ↗

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-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-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-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-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-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-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-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-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-1130-2009 · Feb 12, 2009 · Terminated
    Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782E. Sizes: 8 CM in length, REF (240) 27782E. Each catheter is provided in a sealed Tyvek plas
  • 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-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-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

…and 16 more.

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Sources and updates

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