Reported Sep 17, 2025 · Ongoing
Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN)
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 26 Inflation Device, Material Numbers (UPN)
6 of 6 products
| Model / number | Product as published |
|---|---|
H74904526011 | Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. |
H74904526052 | 2. |
M0067101140 | 3. |
M001151050 | 4. |
M001151062 | 5. |
M00566670. | 6. |
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Product as published 8714729177029H74904526011, , Lot Numbers: 34915076, 35065978 8714729127062H74904526052, , Lot Numbers: 34915078, 34915220 8714729755814M0067101140, , Lot Numbers: 34892421 8714729183624M001151050, , Lot Numbers: 34966934 8714729137542M001151062, , Lot Numbers: 34873498 8714729755241M00566670, , Lot Numbers: 35045668. - Amount recalled
- 39739 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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