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U.S. Department of Health and Human Services

Class 2 Device Recall Ascenda Intrathecal Catheter

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 Class 2 Recall
Ascenda Intrathecal Catheter
see related information
Date Posted June 04, 2014
Recall Status1 Open
Recall Number Z-1723-2014
Recall Event ID 68295
Premarket Approval
PMA Number
P860004/S125
Product Classification Pump, Infusion, Implanted, Programmable - Product Code LKK
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.
Code Information N457062003
Recalling Firm/
Manufacturer
Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis, Minnesota 55432-3568
Manufacturer Reason
for Recall
Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results
Action There was only one consignee affected by the recall. The consignee was contacted by phone on 5/2/14 and the information was provided verbally. General Manager & Vice President, Pain Stimulation/Targeted Drug Delivery spoke via phone with the physician managing the patient. The following information was provided: "Medtronic identified the potential for endotoxin levels exceeding USP requirements on product recently implanted (Model 8780, serial number N457062003). "There may be the potential for serious patient injury due to endotoxin within the first hours after implant. "Medtronic recommends observing the patient for symptoms of meningitis. Also to be aware that CSF would not test with a positive culture because endotoxin induced meningitis results in an aseptic meningitis. The physician expressed confidence in the management of the patient and stated he was calling the nursing care facility to increase monitoring of the patient. Subsequent information was received regarding the patient indicating there were no signs of an endotoxin reaction.
Quantity in Commerce 1
Distribution Distributed in the state of CT.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LKK and Applicant = MEDTRONIC INC.
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