FDA Device recall Z-0049-2013
Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass proc…
- FDA Device
- Class II
- terminated
- Published 2012-10-17
On 2012-10-17 the FDA classified a Class II recall of Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass proc… by Terumo Cardiovascular Systems, citing 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 rep….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0049-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-25 |
| Published | 2012-10-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | 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, VA, WA, WI, WV |
Product
Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Reason
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
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0049-2013%22
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