Elana, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1143-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.

Product Classification:

Class II

Date Initiated: February 14, 2013

Date Posted: April 24, 2013

Recall Number: Z-1143-2013

Event ID: 64538

Reason for Recall:

Distribution of an unapproved device into interstate commerce.

Status: Terminated

Product Quantity: 3 devices

Code Information:

Model 280, S/N 776, S/N 706, S/N 758

Distribution Pattern:

Distributed in the states of Pennsylvania, Texas, and New York.

Voluntary or Mandated:

Voluntary: Firm initiated