Intuitive Surgical Needle Driver Recall Due to Grip Cable Failures
Intuitive Surgical is recalling 8MM Large Suture Cut Needle Drivers (Model 471296) due to complaints of frayed or broken grip cables. Affected instruments may lose functionality during surgical 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: FDA Class II recall involving actual mechanical defects (frayed or broken grip cables) on a reusable surgical instrument with potential to impair safe use. No illnesses or injuries have been reported; score capped at 3 per rubric for risk-of-harm products without reported injury.
Plain-English summary
Intuitive Surgical, Inc. is recalling 8MM Large Suture Cut Needle Drivers (Model 471296) distributed nationwide and internationally. The recall affects 29,723 units with specific batch numbers and UDI codes identified by the FDA.
The devices are being recalled due to increased complaints of frayed or broken grip cables on the reusable instruments. These grip cable defects could impair the instrument's functionality and potentially compromise its safe use during surgical procedures.
The recalled instruments were distributed throughout the United States and to numerous international locations including Canada, the United Kingdom, Australia, Japan, and many other countries. Healthcare facilities that use these instruments may have received affected units.
Customers who have received recalled units should stop using the affected needle drivers and contact Intuitive Surgical for instructions regarding replacement or service. The FDA reference number for this recall is Z-0879-2025.
The recalled product
- Product
- 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- grip-cable-failure
- equipment-malfunction
Distribution
Distribution scope not specified by the agency.
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