Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)
Recall
- Recall Number
- Z-2534-2025
- Event Number
- 97396
- Firm
- Boston Scientific Corporation
- FEI Number
- 3002095335
- Product Code
- MAV
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- August 5, 2025
- Posted
- September 5, 2025
- Address
- 1 Scimed Pl, Maple Grove, MN, 55311-1565
Description
Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)
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.
Boston Scientific issued an Urgent Medical Device Removal notice to it consignees on 8/5/2025 via letter delivered using a traceable means. The notice explained the issue. potential adverse health consequences associated with use in each device and requested the following instructions be followed: 1. Further distribution or use of any remaining devices affected by this removal should cease immediately. Do NOT use affected devices and remove those devices from your facility s inventory. Segregate the units in a secure place until they can be returned to Boston Scientific. 2. Immediately post this information in a visible location near the affected devices to ensure it is readily accessible to all handlers and users of the device. 3. Forward this notice to any healthcare professional from your organization and to any facilities where affected devices have been transferred, including hospitals or sites within your network. If you are a distributor, this notice must be forwarded to your customers to ensure notification of this device removal is carried out to the end-user level. 4. Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions on page four of the notice 5. Return affected devices. The entire Encore 26 Advantage Kit, NephroMax Kit, or UroMax Ultra Kit must be returned in order to be reimbursed. For questions, please contact your local sales representative.
Worldwide distribution.
68347 units