Large Needle Driver Surgical Instruments Recalled for Frayed or Broken Grip Cables
Intuitive Surgical recalls 8MM Large Needle Driver instruments (Model 470006) due to frayed or broken grip cables affecting reusable instrument function during surgery.
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 a risk-of-harm product—a surgical instrument where grip cable failure could directly impact surgical function and patient safety during procedures. Although no injuries have been reported, the potential for harm during critical surgical use, combined with FDA Class II classification and documented complaints of cable fraying and breakage, warrants a High severity rating.
Plain-English summary
Intuitive Surgical, Inc. is recalling 8MM Large Needle Driver surgical instruments (Model 470006, Part Numbers 470006-12 and 470006-13) with frayed or broken grip cables. A total of 10,603 units have been affected.
The recall is due to increased complaints regarding frayed or broken grip cables on the reusable instruments with jaws. These grip cables control instrument function during surgical procedures.
Affected instruments were distributed nationwide throughout the United States and internationally to over 40 countries including Canada, Australia, Japan, Germany, France, United Kingdom, Brazil, and others. Healthcare facilities and surgical centers using these instruments should verify their inventory against the recalled batch numbers (K10230120, K10230118, K12230119, K11230118, K10230217, K10230623, K10240506, K10240815).
Users with affected instruments should immediately discontinue use and contact Intuitive Surgical for replacement or corrective guidance. Do not use affected instruments in surgical procedures until further instruction from the manufacturer.
The recalled product
- Product
- 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- grip-cable-failure
Distribution
Distribution scope not specified by the agency.
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