Reported May 19, 2021 · Terminated
VenaSeal Closure System
Medtronic Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc. · 4600 Nathan Ln N · Plymouth, MN · 55442-2890
Is this the product you have?
- VenaSeal Closure System
- Lot codes and dates
- Model Number SP-101GTIN 20643169986279
- Serial Numbers
270 of 270 codes
541435414554146541475414854149541505415154152543965439754398543995441754418544195442054618546195462054621546225477154772547735477454775547765479454795547965492454925549265492754928549295502755028550295503055031550325506855069550705507155072550735511355114551155511655437554385543955440554415544255483
- Model Number VS-402GTIN 00613994384089
- Serial Numbers
5383054210542115442155491 GTIN 00643169437937
- Serial Numbers53841 GTIN 00643169931459
- Serial Numbers53928 GTIN 20643169986262
- Serial Numbers
1,122 of 1,122 codes
538215383453835538425384353845538945389653900539265392753929539385414154212542145421554216542175421854220542215422254287542885428954291542925431854320543215432354325543605436254363543675437154372543935439554422545495455054552545555455854559545675456854695546965469754698547775477954780547915479254793
- Model Number VS-404GTIN 00643169437975
- Serial Numbers61677 GTIN 00673978070469
- Serial Numbers62015 GTIN 00673978070872
- Serial Numbers62006 GTIN 00763000240776
- Serial Numbers
614756167361674616786169661933619346193861939619406194161943619476201362022 GTIN 00763000279769
- Serial Numbers61675 Please note that VS-403 is not approved in the U.S. and has not been distributed outside of the United States; the scope of this corrective action will include this product as it is launched in OUS regions beginning Summer 2021
- Amount recalled
- 154,152 units
Where it was sold
Why it was recalled
Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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