Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Ebb Complete Tamponade System Recalled by Clinical Innovations, LLC Due to Potential for a balloon leak in all lots...

Date: December 30, 2014
Company: Clinical Innovations, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Clinical Innovations, LLC directly.

Affected Products

Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO

Quantity: 827 units

Why Was This Recalled?

Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Clinical Innovations, LLC

Clinical Innovations, LLC has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report