Reported Dec 2, 2020 · Terminated
Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 101 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- Box LabelION Fully Articulating Catheter, REF 490105
- VER 08 - Product Usageused to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target
- User ManualION Endoluminal System, System, Instruments, and Accessories User Manual, PN 553990-05 REV. A 2019.12
- Lot codes and dates
- Model Number490105-08
- UDI00886874116258
- Lot/Serial NumberAll
262 of 262 codes
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
- Amount recalled
- 454 catheters
Where it was sold
Why it was recalled
The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
This product could cause temporary or reversible health problems — stop using it.
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