Centrifugal Pump System Lx/Dx Version

510(k) K882758

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

7 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK882758	Date13 Oct 1988Cleared	StatusActive

7 recalls · FDA

2 recalls, same reason
- Terminated Z-0049-2013 FDA Class II initiated 25 Sep 2012
- Terminated Z-0050-2013 FDA Class II initiated 25 Sep 2012
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
3 recalls, same reason
- Terminated Z-0053-2013 FDA Class II initiated 24 Sep 2012
- Terminated Z-0051-2013 FDA Class II initiated 24 Sep 2012
- Terminated Z-0052-2013 FDA Class II initiated 24 Sep 2012
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.
- Terminated Z-0617-2007 FDA Unclassified (pre-2012) initiated 12 Dec 2006
Internal friction may cause the centrifugal manual drive to be inoperable when a disposable pump is attached.
- Terminated Z-0242-2007 FDA Unclassified (pre-2012) initiated 14 Sep 2006 on shared 510(k) K882758
The hand crank handle may separate and detach from the unit during use.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)