Box Label: ION Fully Articulating Catheter — Class II medical device recall Z-0489-2021
Terminated recall by Intuitive Surgical, Inc., reported 2020-12-02, distributed nationwide. The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
| Recall number | Z-0489-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2020-10-23 |
| Classified | 2020-11-25 |
| Reported by FDA | 2020-12-02 |
| Terminated | 2022-12-05 |
| Distributed | Nationwide (US) |
| Quantity | 454 catheters |
| UPC / GTIN / UDI-DI | 00886874116258 |
| Serial numbers | S10181217, S10190103, S10190424, S10190531, S10190605, S10190610, S10190625, S10190710, S10190802, S10190823, S10190829, S10190911, S10191016, S10191023, S10191106, S10191203, S10191210, S10191216, S10191217, S10191231, S10200107, S10200110, S10200220, S10200227, S10200304 and 16 more |
| Model numbers | 490105, 490105-08 |
Product
Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target. User Manual: ION Endoluminal System, System, Instruments, and Accessories User Manual, PN 553990-05 REV. A 2019.12
Reason for recall
The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
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-0489-2021. 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.