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U.S. Department of Health and Human Services

Class 2 Device Recall Abre Venous Selfexpanding Stent System

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  Class 2 Device Recall Abre Venous Selfexpanding Stent System see related information
Date Initiated by Firm February 16, 2024
Date Posted March 19, 2024
Recall Status1 Open3, Classified
Recall Number Z-1317-2024
Recall Event ID 94167
Product Classification Stent, iliac vein - Product Code QAN
Product Abre Venous Self-expanding Stent System, Product Numbers:
a) AB9U14080090;
b) AB9U18100090;
c) AB9G14100090
Code Information a) AB9U14080090, UDI/DI 00643169796294, Batch Number B456626; b) AB9U18100090, UDI/DI 00643169796409, Batch Number B456811; c) AB9G14100090, IUDI/DI 00763000547325, Batch Number B460542
Recalling Firm/
Manufacturer		 Medtronic Inc.
4600 Nathan Ln N
Plymouth MN 55442-2890
For Additional Information Contact PVH Customer Service
763-716-6700
Manufacturer Reason
for Recall		 There is a potential for sterile package breach.
FDA Determined
Cause 2		 Process control
Action Medtronic issued and URGENT: MEDICAL DEVICE RECALL notice to it consignees on 02/16/2024 via FedEx. The notice explained the issue and requested the consignee immediately remove, and quarantine all impacted devices pending a follow-up communication providing additional information pertaining to product retrieval for this issue within 2-3 weeks.
Quantity in Commerce 65 units
Distribution Worldwide distribution - US Nationwide and the countries of Australia, Canary Islands, Colombia, Finland, Germany, Netherlands, Portugal, Spain, Switzerland, United Arab Emirates, 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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