FDA Device recall Z-2949-2020
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845
- FDA Device
- Class II
- ongoing
- Published 2020-09-16
On 2020-09-16 the FDA classified a Class II recall of Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845 by Intuitive Surgical, citing one type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can resu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2949-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-06-10 |
| Published | 2020-09-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Intuitive Surgical |
| Distribution | CA, CO, FL, IL, MA, NC, NJ, NY, OH, PA, TX, VA |
Product
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
Reason
One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.
Identifiers
| code_info | All lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2949-2020%22
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