CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report

Vado Bi-Directional Steerable Sheath 8.8F recalled by Kalila Medical

Kalila Medical is recalling Vado Bi-Directional Steerable Sheath 8.8F, distributed in 11 states. The recall was initiated on 14 Dec 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #0594, exp. 1/19/2018, and Lot #0626, exp. 04/23/2018.

Quantity recalled261 sheaths

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0564-2018
FDA event ID: 78824
Recalling firm: Kalila Medical, Campbell, CA
Classification: Class II
Status: Terminated
Recall initiated: 14 Dec 2017
FDA classified: 9 Feb 2018
Reported: 21 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

14 Dec 2017	Recall initiated by company
9 Feb 2018	Classified by FDA	+57 days
21 Feb 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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.

District of Columbia Florida Georgia Maryland Michigan New Jersey New York Ohio Pennsylvania South Carolina Virginia

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 78824

This product is part of a recall event; the main page for the event is Vado Steerable Sheath 8.8F recalled by Kalila Medical.

Reported	Class	Recall	Company	Reason	Where
21 Feb 2018	CLASS II	Vado Steerable Sheath 8.8F recalled by Kalila Medical	Kalila Medical	Packaging Defects	11 states

More recalls from Kalila Medical

All 2

Reported	Class	Recall	Company	Reason	Where
21 Feb 2018Device	CLASS II	Vado Steerable Sheath 8.8F recalled by Kalila Medical	Kalila Medical	Packaging Defects	11 states

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