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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 8781 see related information
Date Initiated by Firm February 09, 2016
Date Posted March 29, 2016
Recall Status1 Terminated 3 on August 11, 2016
Recall Number Z-1271-2016
Recall Event ID 73426
PMA Number P860004 
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
Product Medtronic, 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 Contact Technical 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
Action Medtronic 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 Commerce 9 (1 still unused)
Distribution Internationally to Japan.
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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