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U.S. Department of Health and Human Services

Class 2 Device Recall Volcano PV 0.035 Catheter

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  Class 2 Device Recall Volcano PV 0.035 Catheter see related information
Date Initiated by Firm June 04, 2015
Date Posted June 25, 2015
Recall Status1 Terminated 3 on October 27, 2015
Recall Number Z-1844-2015
Recall Event ID 71537
510(K)Number K121273  
Product Classification Catheter, ultrasound, intravascular - Product Code OBJ
Product Volcano PV .035 Catheter:
Part number: 88901;

Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.
Code Information Product number 88901; lot number 50002518
Recalling Firm/
Volcano Corporation
2870 Kilgore Rd
Rancho Cordova CA 95670-6133
For Additional Information Contact Lisa Quaglia
Manufacturer Reason
for Recall
During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
FDA Determined
Cause 2
Labeling mix-ups
Action Volcano sent an Urgent Medical Device Recalls lettersdated June 4, 2015 via Federal Express to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine product inventory, quarantine the affected product, complete the attached Customer Return form, and contact Volcano Customer Service at 800-228-4728, option 4 to arrange for the return of any product in inventory.
Quantity in Commerce 162 total devices (included both products)
Distribution US Nationwide Distribution and one account in Canada.
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 = OBJ and Original Applicant = VOLCANO CORPORATION