—#80542

Product

Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter with AMC THROMBOSHIELD (An Antimicrobial * Heparin Coating) For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 746HF8 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output.

FDA product code: DYG — Catheter, Flow Directed
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K934742
Affected lot / code info: Lots: 58612700, 58612702, 58617328, 58617329, 58617330, 58617332, 58617341, 58619706, 58619707, 58619708, 58619709, 58621527, 58621532, 58621535, 58623045, 58623047, 58625221, 58625549, 58627893, 58627899, 58629866, 58630228, 58631725, 58632892, 58633695, 58633696, 58636429, and 58644898.

Why it was recalled

Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode".

Root cause (FDA determination)

Software design

Action the firm took

Edwards initiated the worldwide recall via Urgent Customer Notification letters dated February 9, 2009 and are being sent by Federal Express starting on February 10, 2009. These letters are requesting that customers cease using Swan-Ganz" Continuous Cardiac Output (CCO) Thermodilution Catheter products from the indicated lots and that they return all unused product. Edwards Lifesciences requested that the customer provide written verification of stock and identify any unused product to be returned. Questions should be directed to Technical Service at 800-822-9837.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- AL, AR, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Hawaii, and Puerto Rico and countries of Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, UK, Greece, Ireland, Israel, Italy, Kuwait, Netherlands, Norway, Portugal, Sweden, Colombia, Australia, and Singapore.

Timeline

Recall initiated: 2009-02-09
Posted by FDA: 2009-04-17
Terminated: 2011-04-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #80542. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.