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U.S. Department of Health and Human Services

Class 2 Device Recall Ascenda Intrathecal Catheter Model 8781

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 Class 2 Device Recall Ascenda Intrathecal Catheter Model 8781see related information
Date Initiated by FirmFebruary 09, 2016
Date PostedMarch 29, 2016
Recall Status1 Terminated 3 on August 11, 2016
Recall NumberZ-1271-2016
Recall Event ID 73426
PMA NumberP860004 
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
ProductMedtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
Code Information N558983006
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information ContactTechnical Services
800-707-0933
Manufacturer Reason
for Recall		Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intrathecal Catheter kit. We have identified that this kit may have been produced with incorrect outer package labels. As a result, it may not contain all components necessary to complete the implant procedure.
FDA Determined
Cause 2		Under Investigation by firm
ActionMedtronic sent an "Medical Device Removal" letter dated February 2016. The letter described the problem and the product involved in the recall. The Action Required was to segregate the unused affected product. Their Medtronic Representative will be contacting consignee. For questions contact your Medtronic representative, or call for further questions. (800) 707-0933
Quantity in Commerce9 (1 still unused)
DistributionInternationally to Japan.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = LKK
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