PlainRecalls
FDA Devices Moderate Class II Ongoing

TENACIO Pump with InhibiZone; UPN: 72404429;

Reported: October 22, 2025 Initiated: September 11, 2025 #Z-0138-2026

Product Description

TENACIO Pump with InhibiZone; UPN: 72404429;

Reason for Recall

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

Details

Units Affected
59 units
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Location
Marlborough, MA

Frequently Asked Questions

What product was recalled?
TENACIO Pump with InhibiZone; UPN: 72404429;. Recalled by Boston Scientific Corporation. Units affected: 59 units.
Why was this product recalled?
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 22, 2025. Severity: Moderate. Recall number: Z-0138-2026.