Surgical Retractor Instruments Recalled Due to Frayed or Broken Grip Cables
Intuitive Surgical is recalling approximately 9,303 units of 8MM Small Grasping Retractor instruments due to increased complaints of frayed or broken grip cables affecting reusable surgical instruments 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 medical device recall for a surgical instrument. Although no injuries or deaths have been reported, the defect involves a critical functional component (grip cable) of a reusable surgical instrument used during procedures, constituting a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling approximately 9,303 units of 8MM Small Grasping Retractor instruments (Model 470318, Reference 470318-10) distributed nationwide across all U.S. states and internationally to over 50 countries.
The recall was issued due to increased complaints regarding frayed or broken grip cables on these reusable surgical instruments. These small grasping retractors are used during surgical procedures, and cable failure could affect the instrument's gripping functionality during use.
The affected units include 39 batch numbers manufactured between June 2023 and January 2024, identified by model and UDI-DI code 00886874112441. Healthcare facilities and surgical teams using these instruments should contact Intuitive Surgical, Inc. for guidance regarding inspection and potential repair or replacement of the affected products.
The recalled product
- Product
- 8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- cable-failure
- mechanical-defect
Distribution
Distribution scope not specified by the agency.
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