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Swan-Ganz Vip 831F75

by Edwards Lifesciences LLC 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00690103218282 UDI-DI Date16 Mar 2026ListedStatusListed GUDID: in commercial distribution

Recalls

6 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2203-2026 FDA Class II initiated 8 Apr 2026
    • Ongoing Z-2202-2026 FDA Class II initiated 8 Apr 2026 on shared 510(k) K231248

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Swan-Ganz Vip
Generic Name
Pulmonary artery balloon catheter, electrical
Model / Ref / Catalog
831F75, 831F75P
Primary DI / UDI-DI
00690103218282
510(k) Number
FDA Product Code
DYG, DQO, DXN, DQE, KRA, DQK, DRS, DSB, QAQ
GMDN Term
Pulmonary artery balloon catheter, electrical
Device Class
Class II
Regulation Number
870.1240, 870.1200, 870.1130, 870.1230, 870.1210, 870.1425, 870.2850, 870.2770, 870.2210
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K160084)

Show all (12)

Cleared under the same submission (K231248)

Show all (12)

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • 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