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.
Reported: June 10, 2015 Initiated: May 5, 2015 #Z-1700-2015
Product Description
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.
Reason for Recall
The product failed to meet the internal established statistical test requirement for heparin activity.
Details
- Recalling Firm
- Edwards Lifesciences, LLC
- Units Affected
- 978
- Distribution
- Worldwide distribution US nationwide, Canada and Europe (IC, BE, IT, GB, FR, DK, CZ, DE, AT, ES, IE, NO, PL)
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Edwards Lifesciences, LLC. Units affected: 978.
Why was this product recalled? ▼
The product failed to meet the internal established statistical test requirement for heparin activity.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 10, 2015. Severity: Moderate. Recall number: Z-1700-2015.
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