Z-0935-2012

FloWire Doppler Guide wires. Volcano Corporation, Rancho Cardova, Ca. The Volcano FloWire Doppler guide wire...

Name: Z-0935-2012 FloWire Doppler Guide wires. Volcano Corporation, Rancho Cardova, Ca. The Volcano FloWire Doppler guide wire...
Creator: Volcano Corporation
Published: 2009-10-06
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2009-10-06 / Terminated / root cause: manufacturing process

FDA source

Volcano Corporation began a recall of 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... on 2009-10-06. The reason FDA records is "Reports of no signal displayed on the monitor when FloWire Doppler Guide wires were connected to the Combomap". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0935-2012
Status: Terminated
Initiated: 2009-10-06
Posted: 2012-02-01
Terminated: 2012-02-01
Recalling firm: Volcano Corporation
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.
Product code: DQX Wire, Guide, Catheter
Reason for recall: Reports of no signal displayed on the monitor when FloWire Doppler Guide wires were connected to the Combomap.
Root cause tag: manufacturing process
FDA 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 to contact their Sales Representative. For questions regarding this recall call 916-281-2790.
Quantity in commerce: 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
Product codes and lots: 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.

Product code DQX

K972762Class IICardiometrics Flowire 300 and Xt 300 Doppler Guide WiresCardio Metrics, Inc. / cleared 1997-10-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)