FDA Device recall Z-2534-2025
Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011
- FDA Device
- Class II
- ongoing
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class II recall of Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011 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-2534-2025 |
| 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 Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and 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. H74904527011, GTIN 08714729180005, Lot Numbers: 34783060, 34849364, 34873499, 34942522, 34976509, 35017763, 3506597…1. H74904527011, GTIN 08714729180005, Lot Numbers: 34783060, 34849364, 34873499, 34942522, 34976509, 35017763, 35065979, 35067000; 2. H74904527052, GTIN 08714729127048, Lot Numbers: 34873681, 34915075, 34942524, 34986473, 34986475. |
|---|
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-2534-2025%22
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