Prograsp Surgical Forceps Recalled Due to Frayed Grip Cables
Intuitive Surgical is recalling 2,852 units of 8MM Prograsp Forceps due to complaints of frayed or broken grip cables. These reusable surgical instruments may lose grip control 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: This is an FDA Class II recall involving mechanical failure of a surgical instrument's grip cables. Although no injuries or hospitalizations are reported, the hazard presents a risk of harm through potential loss of instrument control during surgical procedures.
Plain-English summary
Intuitive Surgical, Inc. is recalling approximately 2,852 units of 8MM Prograsp Forceps (Model 470093). These are reusable surgical forceps with jaws used in minimally invasive surgical procedures.
The company issued this recall due to increased complaints regarding frayed or broken grip cables on these instruments. The grip cables control the grasping function of the forceps.
The affected instruments were distributed nationwide across the United States and internationally to multiple countries. Healthcare facilities and surgical centers using these instruments should stop use immediately and contact Intuitive Surgical for instructions on obtaining replacement units.
The recalled product
- Product
- 8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 2,852
Distribution
Part of a larger recall action
This product is one of 37 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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