Device product
Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)
Z-2534-2025
Product summary
- Event
- Event 97396
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 68347 units
- Official record key
device-enforcement:Z-2534-2025
Official wording
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 information: 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 pattern: Worldwide distribution.
Derived failure modes
-
Foreign material or chemical contamination
foreign material