Reported Aug 22, 2012 · Terminated
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic…
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?
- Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring.
- Lot codes and dates
64 of 64 codes
5916952759169528591743185917432059194314591943155919431659194317591970045919700559197006591970075919700859197009591970105919789759197898591978995919790059197901591979025919790359203374. 5920337559203377592033785920337959203380592033815920707459207075592070765920707759216092592160935921609459216096592160975921609859216099592198465923068759230688592306895923069059230691592306925923388259238962592389635923896459238965592432505924324959247419592474215924742059247422592474235924742459247425
- Amount recalled
- 32,145 units for all products in Recall Event
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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