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Dlp® 66118

by Medtronic, Inc. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

3 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20199150021929 UDI-DI Date11 Oct 2025ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0812-2012 FDA Unclassified (pre-2012) initiated 14 Dec 2011
    • Terminated Z-0808-2012 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

    • Terminated Z-1489-04 FDA Unclassified (pre-2012) initiated 15 Sep 2004

    Spiral tip from DLP VAD cannula may be loose and potentially detach during use.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Dlp®
Generic Name
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
Model / Reference
66118
Primary DI / UDI-DI
20199150021929
510(k) Number
FDA Product Code
DWF
GMDN Term
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
Device Class
Class II
Regulation Number
870.4210
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 18.0 French

Related devices

Cleared under the same submission (K845045)

Show all (12)

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number

Other properties (11)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No