Vado Steerable Sheath 8 — Class II medical device recall Z-0563-2018
Terminated recall by Kalila Medical, reported 2018-02-21, distributed in DC, FL, GA, MD, MI, NJ, NY, OH…. Torn sheath liner material was detected at the proximal end of the device during internal product testing whic
| Recall number | Z-0563-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kalila Medical, Campbell, CA, United States |
| Recall initiated | 2017-12-14 |
| Classified | 2018-02-09 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2018-12-14 |
| Distributed | DC, FL, GA, MD, MI, NJ, NY, OH, PA, SC, VA |
| Quantity | 99 sheaths |
| Lot numbers | 0559, 0571 |
| Model numbers | S8FMU67 |
| Expiration dates | 2018-10-09, 2018-10-19 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0563-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.