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U.S. Department of Health and Human Services

Class 2 Device Recall Volcano TrakBack II Disposable Pullback Device

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  Class 2 Device Recall Volcano TrakBack II Disposable Pullback Device see related information
Date Initiated by Firm August 13, 2014
Date Posted September 12, 2014
Recall Status1 Terminated 3 on June 30, 2015
Recall Number Z-2636-2014
Recall Event ID 69049
510(K)Number K003938  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product Volcano TrakBack II Disposable Pullback Device;
Sterile and nonpyrogenic; Single Use.

TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.
Code Information Part number 91003: All Lots
Recalling Firm/
Manufacturer		 Volcano Corporation
2870 Kilgore Rd
Rancho Cordova CA 95670-6133
For Additional Information Contact Lisa M. Quaglia
978-439-3586
Manufacturer Reason
for Recall		 Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
FDA Determined
Cause 2		 Packaging
Action Volcano sent an Urgent Product Recall Notification letter dated August 13, 2014, to all customers who received the device in the last 25 months. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use of the affected product and return unused devices to the Volcano distribution center. Customers were asked to prepare the attached inventory log and then contact Volcano Customer Service at 800-228-4728, option 4 to arrange for return of any affected product in their inventory. A credit would be issued for any returned product. Customers with questions were asked to call 800-228-4728. For questions regarding this recall call 978-439-3586.
Quantity in Commerce 8251 total devices (3777 US)
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.
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 = DQO and Original Applicant = JOMED, INC.
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