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Durata™ 7120Q-52

by St. Jude Medical, Inc.

Durata 7120Q-52 is an endocardial defibrillation lead (FDA Class III; FDA product code NVY, Permanent defibrillator electrodes) made by St. Jude Medical, Inc., approved under FDA PMA P950022 on 10 May 1996 and listed in FDA GUDID since 2 Feb 2017 (UDI-DI 05414734503037), active as of 23 Oct 2026.

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

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

3 closed

Documents

PMA P950022

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05414734503037 UDI-DI Date2 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP950022 Date10 May 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P950022 decided 10 May 1996 Active
  • FDA GUDID UDI-DI 05414734503037 listed 2 Feb 2017 Listed

Recalls

3 recalls · FDA

    • Terminated Z-0660-2016 FDA Class I initiated 3 Nov 2015 on shared PMA P950022

    Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.

    • Terminated Z-0458-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011 on shared PMA P950022

    The recall was initiated because St. Jude Medical has confirmed the failures associated with all cause insulation failure on the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads with specific emphasis on externalized conductors.

    • Terminated Z-0457-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011 on shared PMA P950022

    St. Jude Medical has confirmed the failures associated with all cause insulation failure on the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads with specific emphasis on externalized conductors.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

  1. Approved FDA PMA P950022
  2. Recall initiated FDA recalls Z-0458-2012
  3. Recall initiated FDA recalls Z-0457-2012
  4. Recall initiated FDA recalls Z-0660-2016
  5. Listed FDA GUDID 05414734503037

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name
Durata™
Generic name
Endocardial defibrillation lead
Model / Ref / Catalog
7120Q-52
Primary DI / UDI-DI
05414734503037
PMA number
FDA product code
NVY
GMDN term
Endocardial defibrillation lead
Device class
Class III
GUDID distribution status
In Commercial Distribution
Size
Length — 52 Centimeter

Related devices

Category: Endocardial defibrillation lead

Cleared under the same submission (P950022)

and 8 more cleared under P950022

Other devices from St. Jude Medical, Inc.

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

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Combination product
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)