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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Product Detail

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.
Recall Number Z-1723-2014
Classification Class II
Code Info N457062003
Product Distributed Qty 1
Reason For Recall Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.

Event Detail

Event Id 68295
Product Type Devices
Status Ongoing
Recalling Firm Medtronic Neuromodulation
City Minneapolis
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-02
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distributed in the state of CT.