FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial and venous blood parameter modules, catalog 500AV.
- Recall number
- Z-2680-2011
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial and venous blood parameter modules, catalog 500AV.
- Status
- Terminated
- Initiated
- 2011-04-21
- Posted
- 2011-06-28
- Terminated
- 2012-08-06
- Reason
- 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
- 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
- 3767 all CDI 500 models
- 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.
- Lot, serial or model codes
- lot 1193-5340.
- 510(k) numbers
- ["K972962"]
- PMA numbers
- not on file
- Product code
- DRY
- Firm FEI
- 1828100
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28