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Sarns Low Jetting Aortic Arch Cannula

by 3M Health Care, Sarns

510(k) K934127

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

41 closed

Documents

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK934127 Date22 Feb 1994ClearedStatusActive

Recalls

41 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2105-2014 FDA Class II initiated 23 May 2014
    • Terminated Z-2099-2014 FDA Class II initiated 23 May 2014

    During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications

  • 4 recalls, same reason

    • Terminated Z-0195-2014 FDA Class II initiated 23 Oct 2013
    • Terminated Z-0196-2014 FDA Class II initiated 23 Oct 2013
    • Terminated Z-0193-2014 FDA Class II initiated 23 Oct 2013
    • Terminated Z-0194-2014 FDA Class II initiated 23 Oct 2013

    During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow Aortic Cannulae and Sarns" Venous Return Cannulae.

  • 6 recalls, same reason

    • Terminated Z-0458-2013 FDA Class II initiated 21 Nov 2012
    • Terminated Z-0461-2013 FDA Class II initiated 21 Nov 2012
    • Terminated Z-0456-2013 FDA Class II initiated 21 Nov 2012
    • Terminated Z-0460-2013 FDA Class II initiated 21 Nov 2012
    • Terminated Z-0459-2013 FDA Class II initiated 21 Nov 2012
    • Terminated Z-0462-2013 FDA Class II initiated 21 Nov 2012

    The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptabl

  • 28 recalls, same reason

    • Terminated Z-1300-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1303-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1302-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1311-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1297-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1295-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1291-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1298-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1308-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1301-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1296-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1290-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1310-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1289-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1305-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1307-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1313-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1292-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1304-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1294-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1314-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1288-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1299-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1293-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1306-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1287-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1309-2012 FDA Not yet classified initiated 23 Feb 2012
    • Terminated Z-1312-2012 FDA Not yet classified initiated 23 Feb 2012

    During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.

    • Terminated Z-0181-06 FDA Unclassified (pre-2012) initiated 19 Oct 2005

    The product is labeled as sterile, but the firm has determined that the suture flange may tear through the front of the package.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DWF
Device Class
Class II
Regulation
21 CFR Part 870.4210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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