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FlexNav™ FNAV-DS-LG

by St. Jude Medical, Inc.

Ref FNAV-DS-LGModel FlexNav Delivery System

FlexNav™ FNAV-DS-LG is a Class III device made by St. Jude Medical, Inc., registered in EUDAMED on 19 Jul 2026 (Basic UDI-DI 5415067TAV1200MB) with CE/MDR certificate MDR 751005 valid until 15 Aug 2027, approved under FDA PMA P190023 on 17 Sep 2021 and listed in FDA GUDID since 20 Sep 2021 (UDI-DI 05415067031389), active as of 25 Oct 2026. 5 FDA recalls are linked to it.

Expiring Expiring in European Union. Active in United States. Also listed in GUDID (US).

CE MDR PMA

Valid until

15 Aug 2027

CE MDR certificate

FDA recalls

5 ongoing

This device is named in the recall

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

PMA P190023

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5415067TAV1200MB Basic UDI-DI 05415067031389UDI-DIDate19 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067031389 UDI-DI Date20 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP190023 Date17 Sep 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5415067TAV1200MB registered 19 Jul 2026 Active· +1 more in the status table
  • FDA PMA P190023 decided 17 Sep 2021 Active
  • FDA GUDID UDI-DI 05415067031389 listed 20 Sep 2021 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 751005 Expiring Supplemented Expires in 276 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    8 Jun 2026
    Expires
    15 Aug 2027
    Reason
    Change approved

Recalls

5 recalls · 5 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-0492-2025 FDA Class II initiated 17 Oct 2024
    • Ongoing Z-0491-2025 FDA Class II initiated 17 Oct 2024
    • Ongoing Z-0495-2025 FDA Class II initiated 17 Oct 2024
    • Ongoing Z-0493-2025 FDA Class II initiated 17 Oct 2024
    • Ongoing Z-0494-2025 FDA Class II initiated 17 Oct 2024

    A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.

Timeline

10 dated events

  1. Approved FDA PMA P190023
  2. Listed FDA GUDID 05415067031389
  3. Recall initiated FDA recalls Z-0492-2025
  4. Recall initiated FDA recalls Z-0491-2025
  5. Recall initiated FDA recalls Z-0495-2025
  6. Recall initiated FDA recalls Z-0493-2025
  7. Recall initiated FDA recalls Z-0494-2025
  8. Certificate issued EUDAMED MDR 751005
  9. Registered EUDAMED 5415067TAV1200MB
  10. Certificate expires EUDAMED MDR 751005

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States FDA PMA Active

Specification

EUDAMED · GUDID

Trade name
FlexNav™
Generic name
Transcatheter heart valve bioprosthesis implantation catheter
Device name
FlexNav Delivery Systems
Model / Ref / Catalog
FNAV-DS-LG, FlexNav Delivery System
Primary DI / UDI-DI
05415067031389
Basic UDI-DI
5415067TAV1200MB
PMA number
FDA product code
NPT
EMDN code
P07038002 Cardiac valve transcatheter implant accessories
GMDN term
Transcatheter heart valve bioprosthesis implantation catheter
Device class
Class III
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 19.0000 French
Length — 107.0000 Centimeter

Related devices

Category: Transcatheter heart valve bioprosthesis implantation catheter

Cleared under the same submission (P190023)

and 8 more cleared under P190023

Similar devices in this category

Other devices filed under CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES.

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)