Axela Sheath 9630ES14A
Axela Sheath 9630ES14A is a Class III device made by Edwards Lifesciences LLC, approved under FDA PMA P140031 on 17 Jun 2015 and listed in FDA GUDID since 10 Jan 2019 (UDI-DI 00690103200782), active as of 9 Nov 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 | Number00690103200782 | Date10 Jan 2019 | StatusListed |
| United States | FDA PMAAPPR | NumberP140031 | Date17 Jun 2015 | StatusActive |
Official records
- AccessGUDID record 00690103200782
- FDA PMA database P140031
Across registries
- FDA PMA P140031 decided 17 Jun 2015 Active
- FDA GUDID UDI-DI 00690103200782 listed 10 Jan 2019 Listed
Recalls
-
- Terminated Z-0835-2019
This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.
-
- Terminated Z-2435-2018
SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
-
- Terminated Z-0293-2018
A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.
Timeline
- Approved FDA PMA P140031
- Recall initiated FDA recalls Z-0293-2018
- Recall initiated FDA recalls Z-2435-2018
- Listed FDA GUDID 00690103200782
- Recall initiated FDA recalls Z-0835-2019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Axela Sheath
- Generic name
- Vascular catheter introduction set, nonimplantable
- Model / Ref / Catalog
- 9630ES14A
- Primary DI / UDI-DI
- 00690103200782
- PMA number
- FDA product code
- NPU, NPT
- GMDN term
- Vascular catheter introduction set, nonimplantable
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional