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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Volcano Corporation
Lot Codes / Batch Numbers
Part number 1400, Serial numbers 011-0318-002, 011-01323-012, 011-01319-001, 011-01319-002, 011-01319-005, 011-01319-006, 011-01319-007, 011-01318-001, 011-01321-003, 011-01321-006, 011-01321-008, 011-01321-009, 011-01322-001, 011-01323-010.
Products Sold
Part number 1400; Serial numbers 011-0318-002; 011-01323-012; 011-01319-001; 011-01319-002, 011-01319-005, 011-01319-006; 011-01319-007; 011-01318-001, 011-01321-003, 011-01321-006; 011-01321-008; 011-01321-009; 011-01322-001, 011-01323-010.
Volcano Corporation is recalling FloWire Doppler Guide wires. Volcano Corporation, Rancho Cardova, Ca. The Volcano FloWire Doppler due to Reports of no signal displayed on the monitor when FloWire Doppler Guide wires were connected to the Combomap.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reports of no signal displayed on the monitor when FloWire Doppler Guide wires were connected to the Combomap.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, FL, MI
Page updated: Jan 10, 2026