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TENACIO Pump without InhibiZone; UPN: 72404420;

FDA Recall #Z-0139-2026 — Class II — September 11, 2025

Recall #Z-0139-2026 Date: September 11, 2025 Classification: Class II Status: Ongoing

Product Description

TENACIO Pump without InhibiZone; UPN: 72404420;

Reason for Recall

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

Recalling Firm

Boston Scientific Corporation — Marlborough, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

0 units

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Code Information

UPN: 72404420; UDI-DI: Lot numbers: 1100720566, 1100720567, 1100720568;

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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