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U.S. Department of Health and Human Services

Class 2 Device Recall Volcano FloWire Doppler Guidewire

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  Class 2 Device Recall Volcano FloWire Doppler Guidewire see related information
Date Initiated by Firm October 06, 2009
Date Posted February 01, 2012
Recall Status1 Terminated 3 on February 01, 2012
Recall Number Z-0935-2012
Recall Event ID 60842
510(K)Number K972762  
Product Classification Wire, guide, catheter - Product Code DQX
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Volcano Corporation
2870 Kilgore Rd
Rancho Cordova CA 95670-6133
For Additional Information Contact Neil O'Connor
916-281-2790
Manufacturer Reason
for Recall		 Reports of no signal displayed on the monitor when FloWire Doppler Guide wires were connected to the Combomap.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQX and Original Applicant = CARDIOMETRICS, INC.
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