HIGH

TENACIO Pump without InhibiZone; UPN: 72404420;

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

Quick Facts at a Glance

Recall Date
September 11, 2025
Hazard Level
HIGH
Brand
Boston Scientific
Geographic Scope
1 states

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter

Full Description

TENACIO Pump without InhibiZone; UPN: 72404420;. Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties.. Classification: Class II. Quantity: 0 units. Distribution: Worldwide distribution - US Nationwide and the country of Canada.

View Original Recall on FDA - Medical Devices

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Product Classification

Product Details

Model Numbers
UPN: 72404420
UDI-DI: Lot numbers: 1100720566
1100720567
1100720568
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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