FDA-Device2014-06-11Class II
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.
Medtronic Neuromodulation
Hazard
Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
Sold states
Distributed in the state of CT.
Affected count
1
Manufactured in
7000 Central Ave Ne, Minneapolis, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1723-2014Don't want to check this manually?
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