CLASS II Device recall · Reported 10 Jun 2015 · FDA Enforcement Report

Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters recalled

Edwards Lifesciences is recalling Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters, distributed nationwide in the US. The recall was initiated on 5 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codeslot number 59860969.

Quantity recalled978

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-1700-2015
FDA event ID: 71169
Recalling firm: Edwards Lifesciences, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 5 May 2015
FDA classified: 2 Jun 2015
Reported: 10 Jun 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

5 May 2015	Recall initiated by company
2 Jun 2015	Classified by FDA	+28 days
10 Jun 2015	Published in enforcement report	+8 days

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

Reason for recall

The product failed to meet the internal established statistical test requirement for heparin activity.

Product as listed by the FDA

Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.

Where it was distributed

Worldwide distribution US nationwide, Canada and Europe (IC, BE, IT, GB, FR, DK, CZ, DE, AT, ES, IE, NO, PL)

Nationwide Delaware

Questions about this recall

Is Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters recalled?

Yes. Edwards Lifesciences recalled Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters on 5 May 2015. The recall is Class II and its status is Terminated. Recall number Z-1700-2015.

Why was it recalled?

The product failed to meet the internal established statistical test requirement for heparin activity.

Which lots are affected?

lot number 59860969.

Where was it sold?

Worldwide distribution US nationwide, Canada and Europe (IC, BE, IT, GB, FR, DK, CZ, DE, AT, ES, IE, NO, PL)

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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