Intuitive Surgical Recalls 8MM Micro Bipolar Forceps Due to Frayed Grip Cables
Intuitive Surgical is recalling 178 units of its 8MM Micro Bipolar Forceps (Model 470171) due to increased complaints of frayed or broken grip cables on the reusable instruments. Affected devices have been 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: FDA Class II recall of a surgical instrument with a documented defect (frayed or broken grip cables). This is a risk-of-harm product, but no injuries or illnesses have been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling 178 units of 8MM Micro Bipolar Forceps (Model 470171, Part Number 470171-15) due to increased complaints regarding frayed or broken grip cables on the reusable instruments.
The affected units were distributed nationwide throughout the United States and to international locations including Canada, Australia, United Kingdom, Japan, South Korea, and many other countries. The recall involves devices manufactured under batch numbers K10230801, K10240425, K10240613, K10240702, and K11231116.
Grip cable failure on these forceps could impair the instrument's ability to function properly during surgical procedures. Facilities that received these instruments should discontinue use and contact Intuitive Surgical for instructions regarding return, replacement, or repair of the affected devices.
The recalled product
- Product
- 8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 178
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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