Clinical Innovations, LLC: Medical Device Recall in 2015 - (Recall #: Z-0123-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 5, 2015

Date Posted: October 21, 2015

Recall Number: Z-0123-2016

Event ID: 72018

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.

Status: Terminated

Product Quantity: 827 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated