Date Initiated by Firm | July 22, 2015 |
Date Posted | September 02, 2015 |
Recall Status1 |
Terminated 3 on April 28, 2016 |
Recall Number | Z-2718-2015 |
Recall Event ID |
71881 |
510(K)Number | K081804 K101777 |
Product Classification |
Catheter for crossing total occlusions - Product Code PDU
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Product | Volcano Pioneer Plus Re-Entry Catheter;
Product Code PPLUS20, Catheter for Crossing Total Occlusions.
Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters within the peripheral vasculature. |
Code Information |
Product Code PPLUS20; All lots |
Recalling Firm/ Manufacturer |
Volcano Corporation 2870 Kilgore Rd Rancho Cordova CA 95670-6133
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For Additional Information Contact | Lisa M. Quaglia 978-439-3586 |
Manufacturer Reason for Recall | Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound Guided Re-Entry Catheters. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | The Volcano Corporation sent an Urgent Medical Device Recall letter dated July 22, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately quarantine and return all affected product in their inventory. Customers were also asked to complete the attached form and fax back to 866-723-2482. Customers with questions were instructed to call 866-861-8923.
For questions regarding this recall call 978-439-3586. |
Quantity in Commerce | 5042 devices |
Distribution | Worldwide Distribution - US (nationwide) Canada, Europe, Saudi Arabia, Iran, Egypt, and Qatar. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = PDU 510(K)s with Product Code = PDU
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