Reported Apr 19, 2023 · Ongoing
Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F…
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
Edward LifesciencesREF 777F8Swan-Ganz CCOmbo VCCO/SvO2/CEDV/VIPThermodilution CatheterExterior Diameter 8F (2.7mm)Usable Length 110 cmRecommended Guidewire size 0.018 (0.46mm)Minimum Introducer size 9F (3.0 mm)
- Lot codes and dates
- Primary DI Number00690103146554/
- Lot
114 of 114 codes
641914206422862064229652642380286423863064243142642431436426068464260685642621686426494664278346642893906428939164289408643043616430436264304363643144766431447764314479643206286432532764328112643281136432811464328115643379796433798064337981643450116434501264355442643622386436223964362240643622416436224264373343643733446437334564381703643832756438327664383277643856096438561064385611643856126438561364398982643989836439898464410910644109116441091264410913644109146442362664423627
- Amount recalled
- 59,094 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
There 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 message.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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