Edwards Lifesciences Swan-Ganz Thermodilution Catheter with AMC THROMBOSHIELD (An Antimicrobial * Heparin Coating) REF:
FDA device recall Z-1240-2009 · posted 2009-04-17 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, Llc
- Reason for recall
- Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode".
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 2,728 units
- Distribution
- 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 Ric
- Date initiated
- 2009-02-09
- Date posted
- 2009-04-17
- Date terminated
- 2011-04-11
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER (K924661) | Baxter Healthcare Corp | 1993-04-08 |