[Recalled] Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring. — The device is being recalled because the firm received multiple complaints rela… | FDA 2012-05

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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 Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Edwards Lifesciences, LLC

• Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260 — Class I
• Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 — Class I
• Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan — Class I
• Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures. — Class III
• Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Product Usage: The Miller balloon atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an accepted technique for pall — Class I
• Thin-Flex Venous Cannula, Model Number:TF292902A — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.