CLASS II ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report

Tenacio Pump without InhibiZone recalled by Boston Scientific

Boston Scientific is recalling Tenacio Pump without InhibiZone, distributed nationwide in the US. The recall was initiated on 11 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUPN: 72404420; UDI-DI: Lot numbers: 1100720566, 1100720567, 1100720568;

Quantity recalled0 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0139-2026
FDA event ID: 97603
Recalling firm: Boston Scientific, Marlborough, MA
Classification: Class II
Status: Ongoing
Recall initiated: 11 Sep 2025
FDA classified: 10 Oct 2025
Reported: 22 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

11 Sep 2025	Recall initiated by company
10 Oct 2025	Classified by FDA	+29 days
22 Oct 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

TENACIO Pump without InhibiZone; UPN: 72404420;

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Worldwide distribution - US Nationwide and the country of Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 97603

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025	CLASS II	Tenacio Pump with InhibiZone recalled by Boston Scientific	Boston Scientific	Other	Nationwide
22 Oct 2025	CLASS II	LGX Preconnect with Tenacio Pump without InhibiZone recalled	Boston Scientific	Other	Nationwide
22 Oct 2025	CLASS II	CXR Preconnect with Tenacio Pump with InhibiZone recalled	Boston Scientific	Other	Nationwide
22 Oct 2025	CLASS II	CX Preconnect with Tenacio Pump without InhibiZone recalled	Boston Scientific	Other	Nationwide
22 Oct 2025	CLASS II	LGX Preconnect with Tenacio Pump with InhibiZone recalled	Boston Scientific	Other	Nationwide
22 Oct 2025	CLASS II	CX Preconnect with Tenacio Pump with InhibiZone recalled	Boston Scientific	Other	Nationwide

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