Safety Alert: Class II: 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.
healthelectronicsClass IIRecalled on Sep 17, 2025
Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052
🔢 68347 units
Sold At: Boston Scientific Corporation(Worldwide distribution.)
Recall #: FDA-DEVICE-Z-2534-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- 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.
Get AI-Powered Summary
Premium members get instant insights to help you understand recalls faster
Instant 1-3 sentence summary
Quick action bullets
Clear guidance on what to do
Summary
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.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Boston Scientific Corporation for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.