Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Boston Scientific Corporation
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2534-2025
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