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N/A 22011 M

by Medtronic PS Medical United States GUDID

Product code JXG

Regulatory status

as of 24 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00763000028466 UDI-DIDate20 Mar 2020ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

31 recalls · 1 ongoing · FDA

    • Ongoing Z-1117-2021 FDA Class II initiated 11 Jan 2021

    Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus

    • Terminated Z-0397-2014 FDA Class II initiated 18 Nov 2013

    Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.

  • 29 recalls, same reason

    • Terminated Z-1128-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1150-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1132-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1124-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1151-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1129-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1149-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1131-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1126-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1135-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1137-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1125-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1139-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1142-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1148-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1144-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1134-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1127-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1143-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1147-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1145-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1141-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1136-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1140-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1138-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1130-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1133-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1152-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1146-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009

    The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.

Specification

GUDID · synced 23 Oct 2026

Trade Name
N/A
Generic Name
Ventriculo-peritoneal/atrial shunt
Model / Reference
22011 M
Primary DI / UDI-DI
00763000028466
510(k) Number
FDA Product Code
JXG
GMDN Term
Ventriculo-peritoneal/atrial shunt
Device Class
Class II
Regulation Number
882.5550
Commercial Distribution
In Commercial Distribution

Related devices

Category: Ventriculo-peritoneal/atrial shunt

Cleared under the same submission (K792007)

Show all (12)

Other devices from Medtronic PS Medical

See all devices from Medtronic PS Medical →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
Other properties (9)
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI 1acd28c7-49e8-43aa-acaf-d29b1a25ba80 35 fields · synced 23 Oct 2026