FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules; and Catalog 500A, CDI 500 Monitor with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and /or venous pH, PCO2, K+, or oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
- Recall number
- Z-0142-2012
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules; and Catalog 500A, CDI 500 Monitor with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and /or venous pH, PCO2, K+, or oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
- Status
- Terminated
- Initiated
- 2011-09-23
- Posted
- 2011-10-31
- Terminated
- 2013-04-11
- Reason
- Terumo CVS identified a defective circuit board, which could potentially cause the CDI monitor to not function after a power loss. Once power is lost, the monitor will not power up again, even if AC or battery power are restored.
- Root cause
- Component design/selection
- Action
- Terumo Cardiovascular Systems Corporation sent an "URGENT MEDICAL DEVICE CORRECTION" notice dated September 23, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides information on what to do in the event of a failure of the device. Additionally, a Customer Response Form was attached to the letter for customers to complete and return. Terumo CVS will schedule the return of affected products for inspection and replacement of defective parts. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this notice.
- Quantity
- 432
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada, Chile, Japan, Philippines, and Thailand.
- Lot, serial or model codes
- Catalog # 500AVHCT, CDI Blood Parameter Monitoring Systerm 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe; serial numbers 1038,1217,1381,1459,1461, 2515, 3022, 3446, 4043, 4260, 5048-5056, 5065-5077, 5082-5085,5094-5101,5118-5125,5142-5149,5158-5169, 5178, 5179, 5190,5197,5198, 5210-5213,5222-5225,5238-5245, 5250-5253,5274-5277, 5282-5285, 5290-5293, 5298-5305, 5318-5321, 5334-5337, 5341-5344,5354-5356,5370-5374, 5383, 5385, 5386, 5516-5521, and 5537-5541. Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. Serial numbers 1258, 1361, 1518, 1571, 1636, 1690,1717,1775,1875,1882, 2026,2292,2413,2459,2832, 2984,3092,3256,3313,3432, 3527, 3633, 3660, 3790, 3825, 4104, 5040-5047, 5057-5064, 5078-5081,5086-5093,5102-5117, 5126-5141, 5150-5157, 5170-5177,5180-5189,5191-5196, 5199-5209,5214-5221, 5226-5237, 5246-5249, 5254-5273, 5278-5281,5286-5289, 5294-5297,5306-5317,5322- 5329, 5345-5348, 5350-5353, 5358-5369, 5375-5382, 5387, 5388, 5500-5515, 5527-5529, 5531,5542,5543,and 5546-5556 Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules. Serial numbers 0033, 0051, 1465, 5330, 5331, 5332, 5333, 5338, 5339, and 5340. Catalog 500A, CDI 500 Monitor with Arterial blood parameter module. Serial numbers 1560 and 5349.
- 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