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.
FDA Recall Z-1700-2015 · Posted 2015-06-02
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Recalling FirmEdwards Lifesciences, LLC
Recall StatusTerminated
Product CodeDYG
Date Initiated2015-05-05
Date Terminated2016-10-17
Product Quantity978
Reason for Recall
The product failed to meet the internal established statistical test requirement for heparin activity.
Firm Action
On 05/05/2015 Edwards sent their consignees a letter including the following instructions:
Once you have verified your inventory, please complete the attached acknowledgement form (even
if you have no inventory) and fax it to Edwards Customer Service at 1-800-422-9329 within three days of receipt of this notification. This is to confirm that you have reviewed this notice and have taken appropriate action. Please call Edwards Customer Service at 1-800-424-3278 to arrange for return of any unused product from the identified lot and obtain information about replacement product. Please call for an RGA prior to returning any unused product and return unused product to the following address:
Edwards Lifesciences
Return Goods/RGA # XXXXXX
1212 Alton Pkwy.,
Irvine, CA 92606-4838
Root Cause
Process control
Distribution Pattern
Worldwide distribution US nationwide, Canada and Europe (IC, BE, IT, GB, FR, DK, CZ, DE, AT, ES, IE, NO, PL)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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