8MM Large Suturecut Needle Driver Recalled for Frayed Grip Cables
Intuitive Surgical is recalling 8MM Large Suturecut Needle Driver instruments due to frayed or broken grip cables. The recall affects 784 units distributed nationwide and internationally.
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: This is an FDA Class II medical device recall. Per the rubric, Class II recalls without reported hospitalizations or injuries fall into the High category when the product poses a risk of harm. The frayed or broken grip cables create a risk during surgical procedures, though no injuries have been reported.
Plain-English summary
Intuitive Surgical is recalling 8MM Large Suturecut Needle Driver instruments (Model 470296) due to increased complaints regarding frayed or broken grip cables. The recall affects 784 units.
These are reusable surgical instruments with grip cables that serve as critical components for surgical use. The complaints of fraying or breaking led to this recall.
The affected instruments were distributed nationwide throughout the United States, including all states and territories, as well as internationally to multiple countries. Specific batch numbers are identified in the recall documentation.
The recalled product
- Product
- 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- cable-fraying
- cable-breaking
Distribution
Distribution scope not specified by the agency.
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