FDA Medical Device Recalls (openFDA)
Kalila Medical: Vado Steerable Sheath 8.8F, REF SS8FMU67, 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.
- Recall number
- Z-0563-2018
- Recalling firm
- Kalila Medical
- Product
- Vado Steerable Sheath 8.8F, REF SS8FMU67, 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.
- Status
- Terminated
- Initiated
- 2017-12-14
- Posted
- not on file
- Terminated
- 2018-12-14
- Reason
- 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
- Under Investigation by firm
- Action
- The recalling firm issued a letter dated 12/14/2017 via FedEx on 12/14/2017.
- Quantity
- 99 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.
- Lot, serial or model codes
- Lot #0559, exp. 10/9/2018, and Lot #0571, exp. 10/19/2018.
- 510(k) numbers
- ["K160721"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 3009749192
- Firm city
- Campbell
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28