Boston Scientific Corporation — Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. M001151062; 6. M0
⚠️ 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.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- August 5, 2025
Worldwide distribution.
What's affected?
- Product
- Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. M001151062; 6. M00566670. (Interventional Cardiology, Peripheral Interventions)
- Lot code
- 34915076
Additional details
1. H74904526011, GTIN 8714729177029, Lot Numbers: 34915076, 35065978; 2. H74904526052, GTIN 8714729127062, Lot Numbers: 34915078, 34915220; 3. M0067101140, GTIN 8714729755814, Lot Numbers: 34892421; 4. M001151050, GTIN 8714729183624, Lot Numbers: 34966934; 5. M001151062, GTIN 8714729137542, Lot Numbers: 34873498; 6. M00566670, GTIN 8714729755241, Lot Numbers: 35045668.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 39739 units.
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