FDA Device recall Z-0563-2018
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,…
- FDA Device
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of 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,… by Kalila Medical, citing 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 proce….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0563-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-14 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Kalila Medical |
| Distribution | DC, FL, GA, MD, MI, NJ, NY, OH, PA, SC, VA |
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.
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.
Identifiers
| code_info | Lot #0559, exp. 10/9/2018, and Lot #0571, exp. 10/19/2018. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0563-2018%22
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