Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2016 - (Recall #: Z-0001-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.

Product Classification:

Class III

Date Initiated: December 11, 2015

Date Posted: October 12, 2016

Recall Number: Z-0001-2017

Event ID: 75118

Reason for Recall:

Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette does not make a proper connection to the CDI H/S Probe. In this situation, blood parameter values for HCT, Hgb, and SO2 do not display.

Status: Terminated

Product Quantity: 140,000 units

Code Information:

6912 , 6913 6914, 6932, 6933 6934, 6922, 6923 6924, CV-6912, CV-6913, CV-6914 Cardiovascular Procedure Kits- Various

Distribution Pattern:

Worldwide Distribution - USA (nationwide) Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated