Intuitive Surgical Monopolar Curved Scissors Recalled for Frayed Grip Cables
Intuitive Surgical recalls 355,547 monopolar curved scissors due to increased complaints of frayed or broken grip cables on these reusable surgical instruments.
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 for a surgical instrument where grip cable failure could compromise device function during surgical use. No deaths or injuries are reported in the source, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling 355,547 units of 8MM Monopolar Curved Scissors, Model 470179, due to increased complaints of frayed or broken grip cables on these reusable instruments.
The instruments include grip cables and jaws for surgical use. The company identified that some units may be affected by cable defects.
The recalled instruments were distributed across all U.S. states and Puerto Rico, as well as to over 40 countries worldwide. Specific batch numbers involved in the recall span from late 2022 through mid-2024, as documented in the FDA notice.
Distributors and healthcare facilities should refer to the official FDA recall notice for complete details about batch numbers, product identifiers, and any instructions from the manufacturer.
The recalled product
- Product
- 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- grip-cable-failure
- instrument-malfunction
Distribution
Distribution scope not specified by the agency.
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