Recall Z-0935-2012 ยท DQX Wire, Guide, Catheter
Volcano Corporation
FloWire Doppler Guide wires. Volcano Corporation, Rancho Cardova, Ca. The Volcano FloWire Doppler guide wire is a single use guide wire intended for use in all blood vessels including both coronary and peripheral arteries to measure blood flow velocities during diagnostics angiography and/or interventional procedures.
| Date | Feb 1, 2012 (initiated Oct 6, 2009) |
| Status | Terminated |
| Reason | Reports of no signal displayed on the monitor when FloWire Doppler Guide wires were connected to the Combomap. |
| Root cause | Employee error |
| Action | Volcano Corporation sent recall letters dated October 6, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and fax the attached Customer Reply Letter so that an RMA could be issued for the return of the unused affected product, and any replacement or credit could be arranged. Customers were instructed to return the Customer Reply letter even if they no longer have the affected product in their inventory. For questions regarding the use of the product. customers were instructed |
| Quantity | 14 in US; 42 to EU and 15 to Japan |
| Distribution | Worldwide Distribution - USA including MI, AZ and FL and the countries of Japan and Europe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972762 | CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES Cardio Metrics, Inc., Oct 14, 1997 |