CDI 500 Blood Parameter Monitoring System recallZ-2742-2015 · Terumo Cardiovascular Systems Corporation · initiated Aug 7, 2015
Class II Terminated All recalls posted in September 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Terumo Cardiovascular Systems Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.
FDA root cause category: Software design
What the company is doing
A voluntary Urgent Medical Device Correction notice that clearly explains initial in-vivo calibration requirements, device operating ranges, and temperature measurements was sent on 08/17/2015, via express mail to consignees of CDI System 500 v1.69. Following the initial notice, Terumo will be updating the Operators Manual and will send the new manual to each consignee when available. One manual per unit at each facility will be provided. Customers with questions and return response forms may contact: Terumo Recall Email: [email protected] Terumo Recall Fax: 734-741-6149 Terumo CVS Customer Service: 1.800.521.2818, Monday - Friday, 8 a.m. 6 p.m. ET.
Recall details
- Recall number
- Z-2742-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 7, 2015
- Posted by the FDA
- Sep 9, 2015
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 4638
- Product code
- DRY
- FDA submissions
- K133658
- Distribution
- Worldwide Distribution-US (nationwide) including DC and PR and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and the countries of Australia, Belgium, Canada, Chile, Colombia, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, United Arab Emirates.
Product description
CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature.
Code information (models, lots, serial numbers)
500A, 500AHCT, 500AV, 500AVHCT CDI Blood Parameter Monitoring System 500; software version 1.69.
Other devices under the same FDA submission
7 devices cleared under K133658 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CDI™ Shunt Sensor CDI510HTerumo Cardiovascular Systems Corporation · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass184 reports
- CDI™ Blood Parameter Monitoring System 500 500AHCTTerumo Cardiovascular Systems Corporation · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass27 reports
- CDI™ Blood Parameter Monitoring System 500 500AVHCTTerumo Cardiovascular Systems Corporation · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass12 reports
- CDI™ H/S Cuvette 1/4 x 1/4 - Japan CV-6914Terumo Cardiovascular Systems Corporation · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass1 death5 reports
- CDI™ H/S Cuvette 3/8 x 3/8 - Japan CV-6913Terumo Cardiovascular Systems Corporation · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass3 reports
- CDI™ H/S Cuvette 1/2 x 1/2 - Japan CV-6912Terumo Cardiovascular Systems Corporation · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass2 reports
- CDI™ H/S Cuvette 3/8 x 3/8 6913Terumo Cardiovascular Systems Corporation · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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