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N/A 46442

by Medtronic PS Medical United States GUDID

Product code GWM

Regulatory status

as of 24 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20643169471522 UDI-DIDate15 Jul 2015ListedStatusIn 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

6 recalls · 1 ongoing · FDA

    • Ongoing Z-2412-2023 FDA Class II initiated 28 Jun 2023

    Product labeling contains incorrect expiration date

  • 5 recalls, same reason

    • Terminated Z-1920-2014 FDA Class I initiated 9 Jun 2014
    • Terminated Z-1923-2014 FDA Class I initiated 9 Jun 2014
    • Terminated Z-1921-2014 FDA Class I initiated 9 Jun 2014
    • Terminated Z-1922-2014 FDA Class I initiated 9 Jun 2014
    • Terminated Z-1924-2014 FDA Class I initiated 9 Jun 2014

    Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.

Specification

GUDID · synced 23 Oct 2026

Trade Name
N/A
Generic Name
Lumbar cerebrospinal fluid drainage catheterization kit
Model / Reference
46442
Primary DI / UDI-DI
20643169471522
510(k) Number
FDA Product Code
GWM, JXG, GWN
GMDN Term
Lumbar cerebrospinal fluid drainage catheterization kit
Device Class
Class II
Regulation Number
882.1620, 882.5550, 882.1460
Commercial Distribution
In Commercial Distribution

Related devices

Category: Lumbar cerebrospinal fluid drainage catheterization kit

Cleared under the same submission (K984053)

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
  • Prescription Use
  • Lot / Batch Number
Other properties (10)
  • Implantable: No
  • 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 ed82e24e-1545-4e87-8094-937c38c885a8 35 fields · synced 23 Oct 2026