FDA Device recall Z-2533-2025
Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011
- FDA Device
- Class II
- ongoing
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class II recall of Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011 by Boston Scientific, citing 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 determin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2533-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-05 |
| Published | 2025-09-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
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)
Reason
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.
Identifiers
| code_info | 1. H74904526011, GTIN 8714729177029, Lot Numbers: 34915076, 35065978; 2. H74904526052, GTIN 8714729127062, Lot Number…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. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2533-2025%22
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