Recall Z-2718-2015 ยท PDU Catheter For Crossing Total Occlusions
Volcano Corporation
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.
| Date | Sep 2, 2015 (initiated Jul 22, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 5042 devices |
| Distribution | Worldwide Distribution - US (nationwide) Canada, Europe, Saudi Arabia, Iran, Egypt, and Qatar. |
| FDA record | Open on fda.gov |