Recall Z-2172-2014— Medtronic Neuromodulation

Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2014-07-11, terminated 2015-07-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784. The 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 an Ascenda Intrathecal Catheter.. Reason: Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which are used with the implantable SynchroMed drug infusion pump. This recall is being conducted due to a single component of the catheter, the retainer ring, not meeting specification criteria. There is a possibility of unintentional disconnection of the catheter from the pump, or difficulty in disconne.

Recalling firm

Medtronic Neuromodulation

Classification

Class II

Status

Terminated

Initiated

2014-07-11

Terminated

2015-07-17

Firm location

Minneapolis, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.