Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2012 - (Recall #: Z-0052-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.

Product Classification:

Class II

Date Initiated: September 24, 2012

Date Posted: October 17, 2012

Recall Number: Z-0052-2013

Event ID: 62059

Reason for Recall:

Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass.

Status: Terminated

Product Quantity: 213 units

Code Information:

Catalog number: 6380 and serial numbers: 5007, 5028-5030, 5032, 5075, 5076, 5135,6010,6013,6025,6030,6116, 7000-7197,7372, and 7373.

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and the countries of Bangladesh, Seoul Korea, Chile, Brazil, Venesuela, Thailand, Mexico, India, Taiwan, Canada, Dominican Republic, Guatemala, Ecuador, Germany, Republic of Georgia, Hong Kong, Japan, United Arab Emirates (UAE), Japan, Belgium, Phillipines, Singapore, and South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated