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Recall Observatory FDA recall evidence

Device product

TENACIO Pump without InhibiZone; UPN: 72404420;

Z-0139-2026

September 11, 2025

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 97603
Status
Ongoing
Classification
Class II
Quantity
0 units
Official record key
device-enforcement:Z-0139-2026

Official wording

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

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

Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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