CLASS II Device recall · Reported 22 Aug 2012 · FDA Enforcement Report

Swan-Ganz Thermodilution VIP Catheters recalled by Edwards Lifesciences

Edwards Lifesciences is recalling Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters, distributed nationwide in the US. The recall was initiated on 11 May 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes59197000, 59197001, 59216091, 59218827, 59238961

Quantity recalled32,145 units for all products in Recall Event

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2192-2012
FDA event ID: 62278
Recalling firm: Edwards Lifesciences, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 11 May 2012
FDA classified: 12 Aug 2012
Reported: 22 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

11 May 2012	Recall initiated by company
12 Aug 2012	Classified by FDA	+93 days
22 Aug 2012	Published in enforcement report	+10 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring.

Where it was distributed

Worldwide Distribution-USA (nationwide) and the countries of Canada, Japan, EMEA (Europe, Middle East and Africa), Asia Pacific, (Hong Kong, Indonesia, Malaysia, Australia, and Taiwan, Thailand), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).

Nationwide

Questions about this recall

Is Swan-Ganz Thermodilution VIP Catheters recalled?

Yes. Edwards Lifesciences recalled Swan-Ganz Thermodilution VIP Catheters on 11 May 2012. The recall is Class II and its status is Terminated. Recall number Z-2192-2012.

Why was it 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.

Which lots are affected?

59197000, 59197001, 59216091, 59218827, 59238961

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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