Intuitive Surgical Recalls 8MM Mega Needle Driver for Frayed or Broken Grip Cables
Intuitive Surgical is recalling 38,438 units of the 8MM Mega Needle Driver surgical instruments due to complaints of frayed or broken grip cables.
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 surgical instrument where mechanical failure of grip cables could impair function during procedures. No injuries have been reported, placing this within the 'High' severity tier per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Intuitive Surgical, Inc. is recalling approximately 38,438 units of the 8MM Mega Needle Driver (Model 470194) surgical instruments.
The recall was initiated due to increased complaints regarding frayed or broken grip cables on the reusable instruments with jaws. These instruments were distributed nationwide in the United States and internationally.
Affected customers should contact Intuitive Surgical for guidance regarding the affected units, including information on replacement or repair options.
The recalled product
- Product
- 8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 38,438
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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