FDA recall Z-0139-2026

Boston Scientific Corporation · Class II · device

Product

TENACIO Pump without InhibiZone; UPN: 72404420;

Reason for recall

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

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status
Ongoing
Initiation date
2025-09-11
Report date
2025-10-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0139-2026