HEM-O-LOK Clip Applier Recalled for Frayed or Broken Grip Cables
Intuitive Surgical is recalling 29,559 units of the 8MM Large HEM-O-LOK Clip Applier for frayed or broken grip cables on the reusable surgical instrument jaws.
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 medical device recall for a surgical instrument with reported mechanical defects. No injuries have been reported, but the grip cable failure represents a risk-of-harm product where the defect could compromise surgical functionality.
Plain-English summary
Intuitive Surgical, Inc. is recalling 29,559 units of the 8MM Large HEM-O-LOK Clip Applier (Model 470230, Part Numbers 470230-12 and 470230-14) due to complaints of frayed or broken grip cables on the reusable instrument. This surgical device applies hemostatic clips during procedures to help control bleeding.
The recall was initiated due to increased complaints regarding the grip cable defects. Multiple affected batch numbers have been identified.
Recalled devices were distributed nationwide throughout the United States and internationally to numerous countries worldwide.
Customers and healthcare facilities using affected devices should immediately contact Intuitive Surgical for guidance. The manufacturer will provide information regarding replacement, repair, or return options.
The recalled product
- Product
- 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- grip-cable-failure
- surgical-instrument-malfunction
Distribution
Distribution scope not specified by the agency.
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