Device product
Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8780 Ascenda Intrathecal Catheter.
Z-1723-2014
Product summary
- Event
- Event 68295
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-1723-2014
Official wording
Reason: Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
Code information: N457062003
Distribution pattern: Distributed in the state of CT.
Derived failure modes
-
Unknown
Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.