The Recall Desk
HighFDA (Devices)·Z-0867-2025·Announced 2025-01-22

Intuitive Surgical Clip Applier Instruments Recalled for Frayed or Broken Cables

Intuitive Surgical has recalled approximately 30,316 units of its 8MM Medium-Large Clip Applier instruments (Model 470327) due to reports of frayed or broken grip cables on the reusable surgical tools.

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: Class II medical device recall with real complaints of mechanical failure (frayed/broken cables) on a surgical instrument. While the hazard presents risk of harm during use, no injuries or hospitalizations have been reported, placing this in the risk-of-harm category without reported injury.

Plain-English summary

Intuitive Surgical, Inc. is recalling the 8MM Medium-Large Clip Applier instruments (Model 470327) used in surgical procedures. The affected instruments contain grip cables that are prone to fraying or breaking during use.

The recall addresses complaints of increased failures with the grip cables on these reusable surgical instruments. A total of 30,316 units have been identified across multiple batch numbers. The affected instruments were distributed nationwide across the United States and internationally to healthcare providers.

Healthcare providers and patients should verify if they have affected units using the batch numbers provided in the FDA recall notice. If an affected instrument is identified, contact Intuitive Surgical for replacement or disposal instructions. Do not use affected instruments in surgical procedures.

The recalled product

Product
8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Instruments
Hazard
  • cable-failure
  • mechanical-defect

Distribution

Distribution scope not specified by the agency.

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