Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall IVUS Catheter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall IVUS Catheter see related information
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 K101777  K081804  
Product Classification Catheter for crossing total occlusions - Product Code PDU
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
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
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 = PDU and Original Applicant = MEDTRONIC INC.
510(K)s with Product Code = PDU and Original Applicant = MEDTRONIC VASCULAR
-
-