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
Reported: December 2, 2020 Initiated: October 23, 2020 #Z-0489-2021
Product Description
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.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 454 catheters
- Distribution
- US Nationwide distribution including in the states of CA, CO, DC, FL, IA, IL, MA, MD, MI, MN, NC, NJ, NY, OH, PA, TX, UT, and VA.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Intuitive Surgical, Inc.. Units affected: 454 catheters.
Why was this product recalled? ▼
The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 2, 2020. Severity: Moderate. Recall number: Z-0489-2021.
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