Durata™ 7120/75
Durata 7120/75 is an endocardial defibrillation lead (FDA Class III; FDA product code LWS, Implantable cardioverter defibrillator (non-CRT)) 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 05414734502108), active as of 23 Oct 2026. 3 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05414734502108 | Date2 Feb 2017 | StatusListed |
| United States | FDA PMAAPPR | NumberP950022 | Date10 May 1996 | StatusActive |
Official records
- AccessGUDID record 05414734502108
- FDA PMA database P950022
Across registries
- FDA PMA P950022 decided 10 May 1996 Active
- FDA GUDID UDI-DI 05414734502108 listed 2 Feb 2017 Listed
Recalls
-
- Terminated Z-0660-2016
Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
-
- Terminated Z-0458-2012
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
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.
Timeline
- Approved FDA PMA P950022
- Recall initiated FDA recalls Z-0458-2012
- Recall initiated FDA recalls Z-0457-2012
- Recall initiated FDA recalls Z-0660-2016
- Listed FDA GUDID 05414734502108
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Durata™
- Generic name
- Endocardial defibrillation lead
- Model / Ref / Catalog
- 7120/75
- Primary DI / UDI-DI
- 05414734502108
- PMA number
- FDA product code
- LWS
- GMDN term
- Endocardial defibrillation lead
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 75 Centimeter
Similar devices
Other devices filed under FDA product code LWS (Implantable cardioverter defibrillator (non-CRT)).
- MEDTRONIC. GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276 by MEDTRONIC, INC.
- 6721M-50 by MEDTRONIC, INC.
- Subcutaneous Implantable Defibrillator (S-ICD) System by Boston Scientific
- Gem Model 7227 Implantable Cardioverter Defibrillator by Medtronic Cardiac Rhythm Disease Management
- Guardian ATP II Implantable Cardioverter Defibrillator System by Telectronics Pacing Systems, Inc.
- ANGEION SENTINEL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)SYSTEM AND THE ANGEFLEX TM DEFIBRILLATION LEAD SYSTEM. by MicroPort CRM USA, Inc.
- Ventak Automatic Implantable Cardioverter Defibrillator Systems by Boston Scientific
- LINOX(SMART) S & LINOX(SMART) T Steroid-Eluting Dual-Coil ICD Leads by Biotronik, Inc.
- Durata/Riata ST Optim/Riata ST Family of Leads by Abbott Medical
- VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS by Medtronic Cardiac Rhythm Disease Management