Boston Scientific Encore 26 Inflation Device Recall Due to Foreign Particles
Boston Scientific is recalling Encore 26 Inflation Devices due to potential foreign material particles that could migrate into balloon catheters during use. No injuries have been reported.
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: No illnesses or injuries have been reported, and the hazard is theoretical contamination. This medical device recall with risk-of-harm but no actual injury reports meets the criteria for a High (3) severity score.
Plain-English summary
Boston Scientific Corporation is recalling the Encore 26 Inflation Device, which is used with balloon dilation catheters in interventional cardiology and peripheral intervention procedures. The device is used to create and monitor pressure in the balloon and to deflate it. A total of 39,739 units have been distributed worldwide.
An internal investigation determined that foreign material particles could migrate from affected Encore 26 Inflation Devices into the balloon dilatation catheter during use. No injuries or illnesses have been reported in connection with this recall.
The recall affects specific lot numbers of six product variants, identified by the material numbers H74904526011, H74904526052, M0067101140, M001151050, M001151062, and M00566670.
Patients and healthcare providers should immediately discontinue use of affected devices. Those who have received or used an affected device should contact Boston Scientific or the FDA.
The recalled product
- Product
- Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. M001151062; 6. M00566670. (Interventional Cardiology, Peripheral Interventions)
- Manufacturer
- Boston Scientific Corporation
- Hazard
- particle-migration
- contamination
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 (20)
- 1. H74904526011
- GTIN 8714729177029
- Lot Numbers: 34915076
- 35065978
- 2. H74904526052
- GTIN 8714729127062
- Lot Numbers: 34915078
- 34915220
- 3. M0067101140
- GTIN 8714729755814
- Lot Numbers: 34892421
- 4. M001151050
- GTIN 8714729183624
- Lot Numbers: 34966934
- 5. M001151062
- GTIN 8714729137542
- Lot Numbers: 34873498
- 6. M00566670
- GTIN 8714729755241
- Lot Numbers: 35045668.
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03
- HighPhilips Allura Imaging Systems Hard Drive Degradation Affects Functionality
FDA (Devices) · 2026-06-03