Boston Scientific Encore Inflation Device Recall: Foreign Material Risk
Boston Scientific is recalling Encore 26 Inflation Devices due to the risk that foreign material particles could migrate into balloon dilation catheters during use in interventional procedures.
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: This is an FDA Class II recall involving a medical device used in invasive vascular procedures. While no injuries or illnesses have been reported, the risk of foreign material migrating during use creates potential for patient harm in interventional cardiology procedures.
Plain-English summary
Boston Scientific Corporation is recalling the Encore 26 Inflation Device worldwide. This device is used in interventional cardiology and peripheral intervention procedures to create, monitor, and manage pressure in balloon dilation catheters.
An internal investigation found that foreign material particles could migrate from affected Encore 26 Inflation Devices into balloon dilation catheters during use. The recall affects 68,347 units distributed globally.
Healthcare facilities and practitioners using these devices should review the recall notice and contact Boston Scientific for guidance on affected units and appropriate next steps.
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
- foreign-material
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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