Encore Advantage kits recalled over particles migrating from the inflation device
Boston Scientific Encore Advantage Kits are recalled because foreign material particles could migrate from the Encore 26 Inflation Device into a balloon dilatation catheter. 68,347 units are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; particles migrating into a catheter used inside the body is a potential harm and no injuries are reported.
Plain-English summary
Boston Scientific Encore Advantage Kits, material numbers H74904527011 and H74904527052, used in interventional cardiology and peripheral interventions, are being recalled. Affected lot numbers include 34783060, 34849364, 34873499, 34942522, 34976509 and 35017763, with the full list in the recall notice. The recall covers 68,347 units distributed worldwide.
The Encore 26 Inflation Device, supplied in the kit, is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate it. An internal investigation determined that during use, foreign material particles could migrate from affected devices into a balloon dilatation catheter. The FDA classified the action as Class II.
Hospitals holding these lots should quarantine them and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)
- Manufacturer
- Boston Scientific Corporation
- Hazard
- particulate-migration
- foreign-material
- inflation-device
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- 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
Distribution scope not specified by the agency.
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