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.
- Affected units
- 784
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.
See all 37 products in this recall →Related recalls
Same manufacturer · Intuitive Surgical, Inc.
See all →- Moderateda Vinci SP Instrument Arm Drape may detach during surgical procedures
FDA (Devices) · 2026-07-22
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- HighDa Vinci 5 tower may unintentionally activate the infrared handheld camera
FDA (Devices) · 2026-06-10
- Highda Vinci X and Xi Surgical Systems Recalled for Manipulator Arm Screw Breakage
FDA (Devices) · 2026-05-13
- SevereIntuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect
FDA (Devices) · 2026-05-13
Same hazard · cable fraying
See all →- HighIntuitive Surgical 8MM Force Bipolar Instruments Recalled for Frayed Grip Cables
FDA (Devices) · 2025-01-22
- HighIntuitive Surgical Cobra Grasper Surgical Instruments Recalled for Cable Fraying
FDA (Devices) · 2025-01-22
- HighIntuitive Surgical Clip Applier Recalled for Frayed or Broken Grip Cables
FDA (Devices) · 2025-01-22
- HighIntuitive Surgical Recalls 8MM Mega Needle Driver for Frayed or Broken Grip Cables
FDA (Devices) · 2025-01-22
- HighSurgical Forceps Recalled Due to Frayed or Broken Grip Cables
FDA (Devices) · 2025-01-22