CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvett...

FDA Device Recall #Z-0001-2017 — Class III — December 11, 2015

Recall Summary

Recall Number Z-0001-2017
Classification Class III — Low risk
Date Initiated December 11, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Terumo Cardiovascular Systems Corporation
Location Elkton, MD
Product Type Devices
Quantity 140,000 units

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.

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.

Distribution Pattern

Worldwide Distribution - USA (nationwide) Distribution.

Lot / Code Information

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

Other Recalls from Terumo Cardiovascular Systems Corpora...

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Z-2018-2025 Class II CDI OneView System BPM Probe: Cat. No. CDI75... May 28, 2025
Z-1492-2025 Class II Terumo CDI OneView Monitoring System Hematocrit... Mar 3, 2025
Z-1401-2024 Class II Cardiovascular Procedure Kits that include High... Feb 20, 2024
Z-1346-2023 Class II CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Nu... Mar 1, 2023
Z-1347-2023 Class II CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Nu... Mar 1, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.