Volcano Corporation: Medical Device Recall in 2014 - (Recall #: Z-2636-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.

Product Classification:

Class II

Date Initiated: August 13, 2014

Date Posted: September 24, 2014

Recall Number: Z-2636-2014

Event ID: 69049

Reason for Recall:

Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.

Status: Terminated

Product Quantity: 8251 total devices (3777 US)

Code Information:

Part number 91003: All Lots

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.

Voluntary or Mandated:

Voluntary: Firm initiated