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.
FDA Recall Z-0935-2012 · Posted 2012-02-01
Recalling FirmVolcano Corporation
Recall StatusTerminated
Product CodeDQX
Date Initiated2009-10-06
Date Terminated2012-02-01
Product Quantity14 in US; 42 to EU and 15 to Japan
Reason for Recall
Reports of no signal displayed on the monitor when FloWire Doppler Guide wires were connected to the Combomap.
Firm 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 to contact their Sales Representative.
For questions regarding this recall call 916-281-2790.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution - USA including MI, AZ and FL and the countries of Japan and Europe
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.