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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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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
Distribution Pattern Distributed in the state of CT.

Product Detail

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