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Swan-Ganz True Size 123F6

by Edwards Lifesciences LLC United States GUDID

Product code DYG

Regulatory status

as of 26 Oct 2026

Recall ongoing on a related submission. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00690103000382 UDI-DIDate16 Mar 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Recalls

5 recalls · 1 ongoing · FDA

    • Ongoing Z-2202-2026 FDA Class II initiated 8 Apr 2026 via K233824, on the same 510(k)

    Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

  • 4 recalls, same reason

    • Terminated Z-0763-2019 FDA Class I initiated 21 Dec 2018
    • Terminated Z-0765-2019 FDA Class I initiated 21 Dec 2018
    • Terminated Z-0764-2019 FDA Class I initiated 21 Dec 2018
    • Terminated Z-0762-2019 FDA Class I initiated 21 Dec 2018

    These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

GUDID · synced 22 Oct 2026

Trade Name
Swan-Ganz True Size
Generic Name
Pulmonary artery balloon catheter, electrical
Model / Ref / Catalog
123F6, 123F6P
Primary DI / UDI-DI
00690103000382
510(k) Number
FDA Product Code
DYG, DQE, KRA, DQO
GMDN Term
Pulmonary artery balloon catheter, electrical
Device Class
Class II
Regulation Number
870.1240, 870.1230, 870.1210, 870.1200
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Cleared under the same submission (K160084)

Show all (12)

Cleared under the same submission (K233824)

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Contains Latex
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (6)
  • Implantable: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (1)

  • FDA UDI e07a7d3e-80a6-4eb8-afb3-bd1797cfd929 38 fields · synced 22 Oct 2026