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Open, Classified

TENACIO Pump without InhibiZone; UPN: 72404420;

FDA Recall Z-0139-2026 · Posted 2025-10-10

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeJCW
Date Initiated2025-09-11
Product Quantity0 units

Reason for Recall

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

Firm Action

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

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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