Reported Sep 17, 2025 · Ongoing
Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- Boston Scientific Encore Advantage Kit
- Material Numbers (UPN)1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)
- Lot codes and dates
1. H74904527011GTIN 08714729180005
- Lot Numbers
34783060348493643487349934942522349765093501776335065979350670002. H74904527052GTIN 08714729127048
- Lot Numbers
3487368134915075349425243498647334986475
- Amount recalled
- 68347 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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