Z-2678-2011

Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with Arterial and Venous blood...

Name: Z-2678-2011 Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with Arterial and Venous blood...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2011-04-21
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2011-04-21 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe... on 2011-04-21. The reason FDA records is "Inaccurate readings may result after Methylene Blue, an intravascular dye, is administered to the patient. The presence of Methylene Blue may interfere with the readings from the shunt sensor for the CDI 500 system in a...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2678-2011
Status: Terminated
Initiated: 2011-04-21
Posted: 2011-06-28
Terminated: 2012-08-06
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog AVHCT.
Product code: DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Reason for recall: Inaccurate readings may result after Methylene Blue, an intravascular dye, is administered to the patient. The presence of Methylene Blue may interfere with the readings from the shunt sensor for the CDI 500 system in a way that would cause inaccurate pH values. Because the pH value is used to calculate other values, these parameters could also be affected by the presence of Methylene Blue: K
Root cause tag: design
FDA root cause: Device Design
Action: Terumo sent URGENT MEDICAL DEVICE CORRECTION letters to Chief of Perfusion, Department of Cardiothoracic Surgery or Director of Operating Room Services, dated 4/21/2011. The letter explained the reason for the correction and the potential hazard. The letter stated that Terumo was updating the Operators Manual for all CDI systems and would provide the manuals to all users when available. Consignees with questions should call 1-800-521-2818. Monday- Friday 8 am- 6 pm.
Quantity in commerce: 3767 units (all CDI 500 products)
Distribution: Worldwide distribution, including USA, Australia, Barbados, BELGIUM, BRAZIL, CANADA, Chile, Colombia, Costa Rica, Dominican Republic, ECUADOR, El Salvador, France, Germany, Guatemala, Holland, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Korea, Libya, MALAYSIA, MEXICO, PAKISTAN, PANAMA, Paraguay, Saudi Arabia, SINGAPORE, South Africa, Spain, TAIWAN, THAILAND, The Phillipines, TRINIDAD, UNITED ARAB EMIRATES, Uruguay, Venezuela and Vietnam.
Product codes and lots: lots 1005-5521

Product code DRY

K972962Class II3M Cdi Blood Parameter Monitoring System 5003M Company / cleared 1997-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)