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U.S. Department of Health and Human Services

Class 1 Device Recall Medtronic Intrathecal Catheter

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  Class 1 Device Recall Medtronic Intrathecal Catheter see related information
Date Initiated by Firm July 21, 2006
Date Posted September 09, 2006
Recall Status1 Terminated 3 on June 21, 2007
Recall Number Z-1414-06
Recall Event ID 35931
PMA Number P860004 
Product Classification Intrathecal Catheter - Product Code LKK
Product Medtronic Intrathecal Catheter, Model 8731, (part of infusion systems using Medtronic implantable pumps) The catheter is designed for use in the intrathecal space. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.
Code Information Model 8731 Base Lot Numbers: B011311N, B011421N, B011422N, B011500N, B011721N, B011737N, B011738N, B011786N, N0012097, N0012140, N0012141, N0012521, N0012692, N0012814, N0012815, N0012816, N0013149, N0013150, N0013352, N0013353, N0013354, N0013355, N0013707, N0013710, N0013936, N0014007, N0014236, N0014237, N0014330, N0014331, N0014332, N0014722, N0015050.   *Model 8731 Catheters and Model 8598 Distal Revision kits have a Base Lot number of eight (8) characters plus a two (2) digit suffix that represents serialization within these recalled lots. This list provides just the Base lot Number (the first eight characters of the product Lot No. found on the product labeling).
Recalling Firm/
Manufacturer		 Medtronic Neurological
800 53rd Ave NE
PO Box 1250
Minneapolis MN 55440-1250
Manufacturer Reason
for Recall		 Tip dislodgement during implantation-Medtronic is recalling Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit because the platinum-iridium tip may be dislodged by the guide wire during implantation.
FDA Determined
Cause 2		 Other
Action An Urgent Worldwide Medical Device Recall letter was sent to affected customers 07/20/06 for delivery on 07/21/06. The letter describes the issue, identifies the affected product and list action required by the customer. Affected devices are to be removed from active inventory, quarantined and returned to Medtronic for a warranty credit. A Reply card is asked to be returned. Medtronic Representatives will follow-up by July 28, 2006.
Quantity in Commerce Recalls Z-1414-1415-06-USA - 359 devices. Foreign - 575 devices
Distribution Worldwide Distribution-USA and Austria, Belgium, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Netherlands, Norway, Poland, Portugal, San Marino, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LKK and Original Applicant = MEDTRONIC Inc.
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