Durata™ 7120Q-58
Part of a family of 21 devices: see the family page
Ref 7120Q
Durata™ 7120Q-58 is a Class III device made by St. Jude Medical, Inc., registered in EUDAMED on 16 Jul 2026 (Basic UDI-DI 5415067HVL0001KK), approved under FDA PMA P950022 on 10 May 1996 and listed in FDA GUDID since 10 Apr 2017 (UDI-DI 05414734502818), active as of 7 Nov 2026.
Active
Valid until
23 May 2029
FDA recalls
None ongoingTrust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number5415067HVL0001KK 05414734502818 | Date16 Jul 2026 | StatusActive |
| United States | GUDID listing GUDID | Number05414734502818 | Date10 Apr 2017 | StatusListed |
| United States | FDA PMAAPPR GUDID | NumberP950022 | Date10 May 1996 | StatusActive |
Official records
- EUDAMED public site 5415067HVL0001KK
- AccessGUDID record 05414734502818
- FDA PMA database P950022
Across registries
- EUDAMED Basic UDI-DI 5415067HVL0001KK registered 16 Jul 2026 Active
- FDA PMA P950022 decided 10 May 1996 Active
- FDA GUDID UDI-DI 05414734502818 listed 10 Apr 2017 Listed
Certificates
- G70 014607 0265 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 26 Oct 2026
- Expires
- 23 May 2029
- Reason
- Add device or group
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 05414734502818
- Registered EUDAMED 5415067HVL0001KK
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Durata™
- Generic name
- Endocardial defibrillation lead
- Device name
- Cardiac Defibrillation Lead
- Model / Ref / Catalog
- 7120Q EUDAMED7120Q-58 GUDID
- Primary DI / UDI-DI
- 05414734502818
- Basic UDI-DI
- 5415067HVL0001KK
- PMA number
- FDA product code
- NVY
- EMDN code
- J019001020102 Permanent cardiac defibrillator leads, double coil
- GMDN term
- Endocardial defibrillation lead
- Device class
- Class III
- EU registration type
- Standard device
- EU market of registration
- Belgium
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Size
- Length — 58 Centimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | 7120Q | 7120Q-58 |
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