Intuitive Surgical Fenestrated Grasper Recalled for Frayed or Broken Grip Cables
Intuitive Surgical is recalling its 8MM Tip-Up Fenestrated Grasper due to frayed or broken grip cables on reusable surgical instruments. The defect affects multiple batch numbers produced between 2023 and 2024.
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: FDA Class II recall with no reported hospitalizations or injuries. This represents a risk-of-harm surgical device where injury has not yet been reported, fitting the High severity category.
Plain-English summary
Intuitive Surgical, Inc. is recalling the 8MM Tip-Up Fenestrated Grasper (Model 470347) due to frayed or broken grip cables on reusable surgical instruments. Approximately 72,646 units are affected across multiple production batches from 2023 and 2024.
The manufacturer has received increased complaints regarding the fraying or breakage of grip cables on these reusable instruments. The affected graspers have been distributed nationwide throughout the United States and internationally.
Healthcare facilities and users should immediately stop using the affected instruments and contact Intuitive Surgical for instructions on replacement or repair. Identify affected units using the provided batch numbers and part numbers.
The recalled product
- Product
- 8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- frayed-cables
- grip-malfunction
Distribution
Distribution scope not specified by the agency.
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