Z-2718-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2015
- Initiation Date
- July 22, 2015
- Termination Date
- April 28, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5042 devices
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution - US (nationwide) Canada, Europe, Saudi Arabia, Iran, Egypt, and Qatar.
Code Information
Product Code PPLUS20; All lots