FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, Catalog Number 816373 The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit.
- Recall number
- Z-3214-2011
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, Catalog Number 816373 The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit.
- Status
- Terminated
- Initiated
- 2011-08-29
- Posted
- 2011-09-15
- Terminated
- 2013-03-08
- Reason
- The Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume.
- Root cause
- Component change control
- Action
- Terumo Cardiovascular Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated August 29, 2011 to all affected customers. The letter describes the product, problem, and action to be taken. The letter advises customers to make sure all users are aware of the notice. Customers are instructed to complete and return an attached Customer Response Form. Terumo will replace the software on all monitors of the affected product. Customers with questions or concerns should call Terumo CVS Customer Service 1-800-521-2818.
- Quantity
- 85
- Distribution
- Worldwide Distribution--USA (nationwide) including the states of AL, AR, CA, CO, GA, IL, IN, MS, NC, OH, TN, VA, and WI and countries of Belgium, Columbia, Hong Kong, India, Singapore, and Taiwan.
- Lot, serial or model codes
- Cardioplegia Catalog Number 16414 and Serial Numbers 2060, 3305, 3763, 3823, 3834, 3835, 3851-3876, 3878-3899, 3901, 3902, 3904, 3906-3913, 3915-3933 and 3935. Also, catalog number 816373, Serial numbers 491212, 498329, 505891, 505892, 509307, 510221, 512688, 514493, 517238, 522537, 524438, 527767, 534182, 541101, 545173, 551503, 557425, 563225, 568962 and 576045.
- 510(k) numbers
- ["K960916"]
- PMA numbers
- not on file
- Product code
- DWB
- 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