FDA-Device2025-10-22Class II
TENACIO Pump without InhibiZone; UPN: 72404420;
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
0 units
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
TENACIO Pump without InhibiZone; UPN: 72404420;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0139-2026More Boston Scientific Corporation recalls
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific TheraSphere 360 Y-90 software anomaly may cause incorrect dose calculations
- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for incomplete labeling
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