Intuitive Surgical Recalls Fenestrated Bipolar Forceps Over Frayed Grip Cables
Intuitive Surgical recalls 8MM Fenestrated Bipolar Forceps due to increased complaints about frayed or broken grip cables on 12,340 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 recall of a surgical instrument with a mechanical defect affecting grip cable function. No injuries or hospitalizations have been reported, but the defect directly impacts instrument functionality, qualifying this as a risk-of-harm product where injury has not yet been reported per the rubric.
Plain-English summary
Intuitive Surgical, Inc. is recalling 8MM Fenestrated Bipolar Forceps, Model 470205, following increased complaints about frayed or broken grip cables. This Class II recall affects 12,340 units.
These are reusable surgical forceps with a fenestrated design. The grip cables are the subject of complaints indicating fraying or breakage, which could affect instrument functionality.
Distribution of affected units is nationwide across all U.S. states and territories, as well as to numerous international locations including Canada, United Kingdom, Japan, Australia, Argentina, Brazil, China, Germany, France, India, and others.
Affected units can be identified by Model Number 470205, Part Number 470205-17, UDI-DI code 00886874112359, and specific batch numbers including K10221204, K10221218, K10230103, and others provided by the manufacturer.
The recalled product
- Product
- 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- grip-cable-failure
- mechanical-failure
Distribution
Distribution scope not specified by the agency.
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