FDA-Device2025-10-22Class II
TENACIO Pump with InhibiZone; UPN: 72404429;
Boston Scientific Corporation
Hazard
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
59 units
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
TENACIO Pump with InhibiZone; UPN: 72404429;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0138-2026Don't want to check this manually?
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