Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Abre Venous SelfExpanding Stent System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Abre Venous SelfExpanding Stent Systemsee related information
Date Initiated by FirmDecember 04, 2025
Date PostedJanuary 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1098-2026
Recall Event ID 98157
PMA NumberP200026 
Product Classification Stent, iliac vein - Product Code QAN
ProductAbre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
Code Information UDI-DI (GTIN): 00763000547332 00763000547271 00763000547318 00763000547264 00643169796225 00643169796300 00643169796294 00643169796232 00643169796287 00763000547325 00643169796300 00763000547257 Serial/Lot numbers C112511 C113253 C113795 C117416 C117482 C121084 C123953 C133327 C133329 C134478 C138060 C150325
FEI Number 2183870
Recalling Firm/
Manufacturer		 Medtronic Inc
4600 Nathan Ln N
Plymouth MN 55442-2890
For Additional Information ContactPVH Customer Service
800-716-6700
Manufacturer Reason
for Recall		Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
FDA Determined
Cause 2		Under Investigation by firm
ActionBeginning 04-Dec-2025, Medtronic distributed an Urgent Medical Device Recall notice to all U.S. consignees who have impacted products via mail courier. Consignees were instructed to complete and return a response form to the firm and to return any affected product they may have.
Quantity in Commerce442
DistributionWorldwide - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, Germany, Jordan, Lebanon, Malaysia, Netherlands, New Zealand, Peru, Poland, Russia, Singapore, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = QAN
-
-