Intuitive Surgical Recalls da Vinci Xi Stapler Instruments Due to Motion Risk
Intuitive Surgical is recalling 43 EndoWrist Stapler instruments for the da Vinci Xi system due to a risk of unexpected jaw motion 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 involves a risk-of-harm product (surgical instrument) where injury has not yet been reported, which aligns with the High severity criteria for theoretical hazards without confirmed adverse events.
Plain-English summary
Intuitive Surgical, Inc. is recalling 43 EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. The recall is due to a potential for unexpected motion of the Xi Stapler jaws. This issue relates to a combination of the p5 software and the surgeon quickly transitioning from the clamp to the fire pedal during use.
The affected instruments were distributed nationwide in the states of WI, FL, OH, TX, CA, AZ, IL, MD, MN, NY, OK, HI, MO, IA, KS, PA, and AL. The recall covers specific da Vinci systems with serial numbers listed in the agency's official documentation. The FDA has classified this as a Class II recall.
Healthcare facilities should stop using the affected instruments and contact Intuitive Surgical for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of In
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 43
Distribution
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