Z-0139-2026 Class II Ongoing

Recalled by Boston Scientific Corporation — Marlborough, MA

Recall Details

Product Type
Devices
Report Date
October 22, 2025
Initiation Date
September 11, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
0 units

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.

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Code Information

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