Z-0139-2026Class II

Boston Scientific Corporation

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2025-10-22

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Firm state

Product quantity

0 units

Initiated by

Voluntary: Firm initiated

Reason for recall

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

Product description

TENACIO Pump without InhibiZone; UPN: 72404420;

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →