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SWAN-GANZ CARDIOCATH TRUE SIZE

Edwards Lifesciences LLC · Model 143TNX7 · UDI-DI 00690103198577

DYGDQEDQO Prescription
1
510(k) clearances
4,863
Adverse events (139 deaths)
49
Recalls
48
Facilities

Description

SWAN-GANZ CARDIOCATH TRUE SIZE THERMODILUTION CATHETER

Recalls

DateFirmReason
2026-04-08Becton, Dickinson and CompanyCatheters 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 bl
2026-04-08Becton, Dickinson and CompanyCatheters 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 bl
2025-04-11LeMaitre Vascular, Inc.During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
2023-02-14Edwards Lifesciences, LLCThere is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error
2023-02-14Edwards Lifesciences, LLCThere is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error
2019-11-15Arrow International IncPotential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowl
2019-11-15Arrow International IncPotential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowl
2018-12-21Edwards Lifesciences, LLCThese 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 a
2018-12-21Edwards Lifesciences, LLCThese 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 a
2018-12-21Edwards Lifesciences, LLCThese 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 a

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.