Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140;

FDA device recall Z-2533-2025 · posted 2025-09-05 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

PTM

Quantity affected

39739 units

Distribution

Worldwide distribution.

Date initiated

2025-08-05

Date posted

2025-09-05

Location

Maple Grove, MN