TENACIO Pump without InhibiZone; UPN: 72404420;

FDA device recall Z-0139-2026 · posted 2025-10-10 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Action taken

On September 11, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: For implanted devices: If the device is working properly, no action is required. Further evaluation is recommended for patients who were implanted with an affected device AND are having difficulty inflating or deflating the device. - Check inventory for affected product and return any unused devices. Immediately cease further distribution or use of any unused affected devices. Please pass this notice to any healthcare professional from your organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Please provide Boston Scientific with details of any affected devices that have been transferred to another organization.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

JCW

Quantity affected

0 units

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Date initiated

2025-09-11

Date posted

2025-10-10

Location

Marlborough, MA