Z-0564-2018Class II

Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch...

Name: Z-0564-2018 Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch...
Creator: Kalila Medical
Published: 2017-12-14
License: https://open.fda.gov/license/

Kalila Medical, Inc. / initiated 2017-12-14 / Terminated / root cause: manufacturing process

FDA source

Kalila Medical began a recall of 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... on 2017-12-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0564-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-14
Posted: 2018-02-09
Terminated: 2018-12-14
Recalling firm: Kalila Medical, Inc.
Product: 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 code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: The recalling firm issued a letter dated 12/14/2017 via FedEx on 12/14/2017.
Quantity in commerce: 261 sheaths
Distribution: 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.
Product codes and lots: Lot #0594, exp. 1/19/2018, and Lot #0626, exp. 04/23/2018.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0564-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0563-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-09
Z-0564-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-09

Product code DYB

K162427Class IIVado Bi-Directional Steerable SheathKalila Medical, Inc. / cleared 2017-01-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)