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TactiFlex™ Sensor Enabled™ A-TFSE-JJ

by St. Jude Medical, Inc.

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

Ref A-TFSE-JJ

TactiFlex™ Sensor Enabled™ A-TFSE-JJ 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 31 May 2023 (UDI-DI 05415067034632), 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
European UnionCE/MDR EUDAMED Number5414734ABS0043C3 Basic UDI-DI 05415067034632UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067034632 UDI-DI Date31 May 2023ListedStatusListed GUDID: in commercial distribution
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 05415067034632 listed 31 May 2023 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. Listed FDA GUDID 05415067034632
  3. Recall initiated FDA recalls Z-0110-2026
  4. Recall initiated FDA recalls Z-0111-2026
  5. Recall initiated FDA recalls Z-0109-2026
  6. Recall initiated FDA recalls Z-0113-2026
  7. Recall initiated FDA recalls Z-0112-2026
  8. Registered EUDAMED 5414734ABS0043C3

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™ Sensor Enabled™
Generic name
Cardiac radio-frequency ablation system catheter
Model / Ref / Catalog
A-TFSE-JJ
Primary DI / UDI-DI
05415067034632
Basic UDI-DI
5414734ABS0043C3
PMA number
FDA product code
OAE
EMDN code
C020301 Arrhythmogenic foci radiofrequency ablation catheters
GMDN term
Cardiac radio-frequency ablation 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

Category: Cardiac radio-frequency ablation system catheter

Cleared under the same submission (P220013)

and 8 more cleared under P220013

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)