Intuitive Surgical Recalls ION Fully Articulating Catheters Due to Tip Ring Risk
Intuitive Surgical is recalling 454 ION Fully Articulating Catheters because the distal tip ring may become dislodged during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a component dislodging during a procedure, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Intuitive Surgical, Inc. is recalling 454 ION Fully Articulating Catheters (REF 490105, VER 08). The recall was initiated because the distal tip ring of the catheter may become dislodged during a procedure. These devices are used to navigate within the lung to a planned path in order to sample a target.
The affected units were distributed nationwide in the United States, including in California, Colorado, the District of Columbia, Florida, Iowa, Illinois, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah, and Virginia. The recall covers specific serial numbers listed in the agency's structured data.
Healthcare facilities and users should stop using the affected catheters and contact Intuitive Surgical for instructions on how to return or replace the devices. No specific instructions for consumers are provided in the source text, as these are professional medical devices.
The recalled product
- 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 M
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 454
Distribution
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