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Medtronic Neuromodulation recalls Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter
Recalled June 11, 2014 · FDA recall Z-1723-2014 · Medtronic Neuromodulation
Hazard
Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits. · FDA Class II
Units
1
Sold at
Distributed in the state of CT.
Description
Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
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.
Manufacturer(s)
Medtronic Neuromodulation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →