Recall Z-1723-2014— Medtronic Neuromodulation
Class II · Terminated
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2014-05-02, terminated 2014-10-07. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-02
- Terminated
- 2014-10-07
- Firm location
- Minneapolis, MN, United States
Product description
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.
Reason for recall
Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
Data sourced from openFDA. This site is unofficial and independent of the FDA.