FDA Enforcement
Class II
Ongoing
Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)
Recall: Z-2534-2025
·
Reported September 17, 2025
Enforcement
- Recall Number
- Z-2534-2025
- Event ID
- 97396
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 17, 2025
- Initiation Date
- August 5, 2025
- Classification Date
- September 5, 2025
- Address
- 1 Scimed Pl, N/A, Maple Grove, MN, 55311-1565, United States
Description
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.
Code Info
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.
Distribution
Worldwide distribution.
Quantity
68347 units