# FDA recall Z-0564-2018

> **Kalila Medical** · Class II · device recall initiated 2017-12-14.

## 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.

## 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.

## 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.

## Key facts

- **Recall number:** Z-0564-2018
- **Recalling firm:** Kalila Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-14
- **Report date:** 2018-02-21
- **Termination date:** 2018-12-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Campbell, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0564-2018

## Citation

> AI Analytics. FDA recall Z-0564-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0564-2018. Source: US FDA. Licensed CC0.

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