FDA recall Z-2551-2025

Boston Scientific Corporation · Class II · device

Product

Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000

Reason for recall

Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

Distribution

Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)

Key facts

Status
Ongoing
Initiation date
2025-08-18
Report date
2025-09-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Maple Grove, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2551-2025