Known Identifiers & Locations
FEI Numbers
2916596
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (2)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0004-2007 |
Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000
Distributed and Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588
Reason: Sticky Valve Disk- The valve disk has an increased tendency to stick during operation causing noise and pressure/vacuum alarms.
|
2006-08-25 |
Terminated
|
View Details
|
| Z-0015-2007 |
Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System,
Model Number(s): Catalogue numbers:
#100118-- Short, 14mm graft;
#100121-- Long, 14mm graft;
#100129-- Long, 18mm graft.
Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588
Reason: During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism.
|
2004-01-26 |
Terminated
|
View Details
|
Profile Disclaimer
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