8MM Dual Blade Retractors recalled for frayed or broken grip cables
Intuitive Surgical is recalling 8MM Dual Blade Retractors due to increased complaints of frayed or broken grip cables. This defect affects 783 reusable surgical instruments distributed in the U.S. 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 (frayed or broken grip cables) that poses a risk of harm during surgical procedures. No injuries or illnesses have been reported in the source text, placing this within the rubric category of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling 8MM Dual Blade Retractors (Model 470249, Part Number 470249-09) due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
The affected retractors are reusable surgical instruments. A total of 783 units have been distributed nationwide throughout the United States and to multiple countries including Canada, Australia, Japan, and others.
Specific batch numbers affected are K10230226, K10230316, K10230323, K10230331, K10230518, K10230824, K10230831, K10231130, K10231214, K10240118, K10240208, K10240222, K10240327, K10240509, K10240711, K10240725, K10240801, and K11231116. The UDI-DI code is 00886874112403.
Health care facilities and users in possession of these instruments should discontinue use and contact Intuitive Surgical, Inc. or the FDA for instructions on replacement or repair. Healthcare providers should report any adverse events associated with these retractors to the FDA's MedWatch program.
The recalled product
- Product
- 8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- mechanical-failure
- grip-cable-defect
Distribution
Distribution scope not specified by the agency.
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