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TactiFlex™ Duo Sensor Enabled™ A-TFDM-DF

by St. Jude Medical, Inc.

Part of a family of 24 devices: see the family page

Ref A-TFDM-DF

TactiFlex™ Duo Sensor Enabled™ A-TFDM-DF is a Class III device made by St. Jude Medical, Inc., registered in EUDAMED on 28 Aug 2026 (Basic UDI-DI 5414734ABS0043C3), approved under FDA PMA P220013 on 18 May 2023 and listed in FDA GUDID since 9 Sep 2026 (UDI-DI 05415067052445), active as of 7 Nov 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 P220013

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05415067052445 UDI-DI Date9 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number5414734ABS0043C3 Basic UDI-DI 05415067052445UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP220013 Date18 May 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5414734ABS0043C3 registered 28 Aug 2026 Active
  • FDA PMA P220013 decided 18 May 2023 Active
  • FDA GUDID UDI-DI 05415067052445 listed 9 Sep 2026 Listed

Recalls

5 recalls · 5 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-0110-2026 FDA Class I initiated 10 Sep 2025
    • Ongoing Z-0111-2026 FDA Class I initiated 10 Sep 2025
    • Ongoing Z-0109-2026 FDA Class I initiated 10 Sep 2025
    • Ongoing Z-0113-2026 FDA Class I initiated 10 Sep 2025
    • Ongoing Z-0112-2026 FDA Class I initiated 10 Sep 2025

    Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Timeline

8 dated events

  1. Approved FDA PMA P220013
  2. Recall initiated FDA recalls Z-0110-2026
  3. Recall initiated FDA recalls Z-0111-2026
  4. Recall initiated FDA recalls Z-0109-2026
  5. Recall initiated FDA recalls Z-0113-2026
  6. Recall initiated FDA recalls Z-0112-2026
  7. Registered EUDAMED 5414734ABS0043C3
  8. Listed FDA GUDID 05415067052445

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
TactiFlex™ Duo Sensor Enabled™
Generic name
Cardiac irreversible electroporation system catheter
Model / Ref / Catalog
A-TFDM-DF
Primary DI / UDI-DI
05415067052445
Basic UDI-DI
5414734ABS0043C3
PMA number
FDA product code
QZI, OAE
EMDN code
C020399 Cardiac tissue ablation devices - other
GMDN term
Cardiac irreversible electroporation system catheter
Device class
Class III
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 8.0000 French
Length — 115.0000 Centimeter

Related devices

Cleared under the same submission (P220013)

and 8 more cleared under P220013

Similar devices in this category

Other devices filed under CARDIAC TISSUE ABLATION DEVICES - OTHER.

Other devices from St. Jude Medical, Inc.

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

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)