Z-0049-2013Class II

Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use...

Name: Z-0049-2013 Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-09-25
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-09-25 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only on 2012-09-25. FDA classified it as Class II and gives the reason as "Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly categorized as...". 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-0049-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-25
Posted: 2012-10-11
Terminated: 2014-01-15
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Product code: KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Reason for recall: Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly categorized as follows: " Failure to charge " Failure to hold charge " Failure to operate In the most severe case, a battery malfunction could result in an unexpected loss of arterial flow. In
Root cause tag: design
FDA root cause: Component design/selection
Action: TERUMO sent an Urgent Medical Device Recall letter dated June 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. On 09/25/2012 an URGENT MEDICAL DEVICE RECALL notification and addendum was sent to all consignees. TCS issued this notification as a Safety Advisory to alert all users of the Sarns centrifugal system of the potential for malfunction and remind them to review the appropriate sections of the Operators Manual for the Sarns Delphin Battery. Providing an addendum to the Operators Manual for the Sarns Delphin Battery with additional instruction on the use and charging of a discharged battery. Customers were instructed to review the Medical Device Recall notice; assure that all users are aware of the notice; place the addendum in the Operator's Manual; and confirm receipt of the communication by faxing or emailing the attached Customer Response Form. For questions customers were instructed to call 1-800-521-2818. For questions regarding this recall call 734-741-6173.
Quantity in commerce: 1076
Distribution: Worldwide distribution: USA including: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, UT, VA, WA, WI, and WV. Puerto Rico and internationally to: ALEXANDRIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CENTRO AMERICA, CHILE, COLOMBIA, Dominican Republic, Ecuador, FRANCE, GERMANY, GREECE, Guatamala, HOLLAND, HONG KONG, India, ITALY, Japan, KL SEGUNDO, KOREA, LEICESTERSHIRE, MALAYSA, Malaysia, Mexico, Mexico, Mexico, NETHERLANDS, Panama, Peru, Philippines, RALEIGH, Republic of Georgia, SANTIAGO CHILE, Saudi Arabia, SEOUL KOREA, SHANGHAI, CHINA, Singapore, South Africa, SPAIN, SWITZERLAND, TAIWAN, Thailand, UNITED ARAB EMIRATES (UAE), Uruguay, USA, and Venezuela,
Product codes and lots: Catalog number: 9490; and lot numbers: 0101,1001-1025,1188-1192,1997, 2000-2017, 2019- 2082, 2086-2287, 2290-2446, 2452-2633, 2636-2938, and 2946-3063

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0049-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0049-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-11
Z-0050-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-11

Product code KFM

K882758Class IICentrifugal Pump System Lx/dx Version3M Health Care, Sarns / cleared 1988-10-13

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)