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Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes)

by Medtronic Cardiac Surgical Products

510(k) K022272

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK022272 Date8 Jan 2003ClearedStatusActive

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-1805-2024 FDA Class II initiated 19 Mar 2024

    Potential for unsealed sterile packing.

  • 2 recalls, same reason

    • Terminated Z-0812-2012 FDA Unclassified (pre-2012) initiated 14 Dec 2011
    • Terminated Z-0810-2012 FDA Unclassified (pre-2012) initiated 14 Dec 2011

    Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to p

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  • Withdrawn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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