Recall Z-2533-2025— Boston Scientific Corporation
Class II · Ongoing
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2025-08-05. FDA's recall record names no specific 510(k) clearance for this event. 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). 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..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-05
- Firm location
- Maple Grove, MN, United States
Product description
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)
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.