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FlexNav™ FNAV-LS-SM

by St. Jude Medical, Inc.

Ref FNAV-LS-SMModel FlexNav Loading System; Navitor Loading System

FlexNav™ FNAV-LS-SM is a device classified as Class I in the EU and Class III in the US made by St. Jude Medical, Inc., registered in EUDAMED on 10 Sep 2026 (Basic UDI-DI 5415067TAV1002M5), approved under FDA PMA P190023 on 17 Sep 2021 and listed in FDA GUDID since 20 Sep 2021 (UDI-DI 05415067031433), active as of 23 Oct 2026. 5 FDA recalls are linked to it.

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

CE MDR PMA

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

5 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

PMA P190023

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5415067TAV1002M5 Basic UDI-DI 05415067031433UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067031433 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 5415067TAV1002M5 registered 10 Sep 2026 Active
  • FDA PMA P190023 decided 17 Sep 2021 Active
  • FDA GUDID UDI-DI 05415067031433 listed 20 Sep 2021 Listed

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

8 dated events

  1. Approved FDA PMA P190023
  2. Listed FDA GUDID 05415067031433
  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. Registered EUDAMED 5415067TAV1002M5

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
FlexNav™
Generic name
Self-expandable heart valve bioprosthesis collapsing tool, single-use
Device name
Transcatheter Aortic Valve, Loading
Model / Ref / Catalog
FNAV-LS-SM, FlexNav Loading System, Navitor Loading System
Primary DI / UDI-DI
05415067031433
Basic UDI-DI
5415067TAV1002M5
PMA number
FDA product code
NPT
EMDN code
P07038002 Cardiac valve transcatheter implant accessories
GMDN term
Self-expandable heart valve bioprosthesis collapsing tool, single-use
Device class
Class I EUDAMED
Class III GUDID
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class III

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Self-expandable heart valve bioprosthesis collapsing tool, single-use

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)