Volcano Corporation: Medical Device Recall in 2015 - (Recall #: Z-2718-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 22, 2015

Date Posted: September 9, 2015

Recall Number: Z-2718-2015

Event ID: 71881

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.

Status: Terminated

Product Quantity: 5042 devices

Code Information:

Product Code PPLUS20; All lots

Distribution Pattern:

Worldwide Distribution - US (nationwide) Canada, Europe, Saudi Arabia, Iran, Egypt, and Qatar.

Voluntary or Mandated:

Voluntary: Firm initiated