CLASS II Device recall · Reported 21 Oct 2015 · FDA Enforcement Report

The Ebb Complete Tamponade System recalled by Clinical Innovations

Clinical Innovations is recalling The Ebb Complete Tamponade System, distributed nationwide in the US. The recall was initiated on 5 Jan 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesManufacturing lot 1214-F-403 and 1214-V-424

Quantity recalled827 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-0123-2016
FDA event ID: 72018
Recalling firm: Clinical Innovations, Murray, UT
Classification: Class II
Status: Terminated
Recall initiated: 5 Jan 2015
FDA classified: 15 Oct 2015
Reported: 21 Oct 2015
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

5 Jan 2015	Recall initiated by company
15 Oct 2015	Classified by FDA	+283 days
21 Oct 2015	Published in enforcement report	+6 days

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

Reason for recall

Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.

Where it was distributed

Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.

Nationwide Alabama Florida Indiana Louisiana Maryland Mississippi North Carolina Tennessee

Questions about this recall

Why was it recalled?

Which lots are affected?

Manufacturing lot 1214-F-403 and 1214-V-424

Where was it sold?

Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.

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.

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