Kalila Medical: Medical Device Recall in 2018 - (Recall #: Z-0564-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.

Product Classification:

Class II

Date Initiated: December 14, 2017

Date Posted: February 21, 2018

Recall Number: Z-0564-2018

Event ID: 78824

Reason for Recall:

Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the manufacturing process.

Status: Terminated

Product Quantity: 261 sheaths

Code Information:

Lot #0594, exp. 1/19/2018, and Lot #0626, exp. 04/23/2018.

Distribution Pattern:

Distribution was made to DC, FL, GA, MD, MI, NJ, NY, OH, PA, SC, and VA. There was also military/government distribution. There was no foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated