—#136322

Product

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 product code: DYG — Catheter, Flow Directed
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K940795
Affected lot / code info: lot number 59860969.

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 1 Edwards Way, Irvine, California 92614-5688

Distribution

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

Timeline

Recall initiated: 2015-05-05
Posted by FDA: 2015-06-02
Terminated: 2016-10-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136322. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.