Livewire™ 402271

by St. Jude Medical Cardiovascular Division

Livewire™ 402271 is a Class III device made by St. Jude Medical Cardiovascular Division, approved under FDA PMA P960016 on 4 May 1999 and listed in FDA GUDID since 23 Sep 2014 (UDI-DI 05414734200301), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 closed

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number05414734200301 UDI-DI	Date23 Sep 2014Listed	StatusListed GUDID: in commercial distribution
United States	FDA PMAAPPR from GUDID Approved	NumberP960016	Date4 May 1999Decided	StatusActive

Official records

AccessGUDID record UDI-DI 05414734200301
FDA PMA database PMA number P960016

Across registries

2 registries list this device

FDA PMA P960016 decided 4 May 1999 Active
FDA GUDID UDI-DI 05414734200301 listed 23 Sep 2014 Listed

Recalls

1 recall · FDA

- Terminated Z-2313-2008 FDA Unclassified (pre-2012) initiated 5 Jun 2008
St. Jude Medical has initiated a recall of one lot of Livewire TC" Ablation Catheter. The product was mis-labelled as having an 8 mm tip instead of 4 mm tip. This could potentially result in elevated temperatures and formation of coagulum at the tip electrode. If this coagulum were to detach from the product, the worst case this could potentially result in embolization.

Timeline

3 dated events

4 May 1999 Approved FDA PMA P960016
5 Jun 2008 Recall initiated FDA recalls Z-2313-2008
23 Sep 2014 Listed FDA GUDID 05414734200301

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name: Livewire™
Generic name: Cardiac radio-frequency ablation system catheter
Model / Ref / Catalog: 402271

Primary DI / UDI-DI: 05414734200301
PMA number: P960016
FDA product code: LPB
GMDN term: Cardiac radio-frequency ablation system catheter

Device class: Class III
GUDID distribution status: In Commercial Distribution

MRI safety: MR Unsafe

Size: Catheter Gauge — 7 French

Similar devices in this category

Other devices filed under Cardiac radio-frequency ablation system catheter.

Other devices from St. Jude Medical Cardiovascular Division

See all devices from St. Jude Medical Cardiovascular Division →

Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)