The Recall Desk
HighFDA (Devices)·Z-0883-2025·Announced 2025-01-22

Intuitive Surgical recalls 8MM Force Bipolar surgical instruments due to grip cable failures

Intuitive Surgical is recalling approximately 46,759 8MM Force Bipolar IS4000 surgical instruments nationwide and internationally due to reports of frayed or broken grip cables that could compromise instrument function during surgical use.

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 recall of a reusable surgical instrument with a reported mechanical failure (frayed or broken grip cables) that could impair device function during surgical procedures. This qualifies as a risk-of-harm product; however, no injuries or illnesses have been reported to date.

Plain-English summary

Intuitive Surgical, Inc. is recalling the 8MM Force Bipolar IS4000 (Model 471405), a reusable surgical instrument used in surgical procedures. The recall involves 46,759 units distributed nationwide in the United States and internationally.

The recall is due to increased complaints of frayed or broken grip cables on the reusable instruments. The grip cables are essential to the instrument's jaw mechanism; if frayed or broken, they could compromise the instrument's ability to grip tissue properly during surgical use.

The affected devices were distributed nationwide throughout all U.S. states, territories, and Puerto Rico, as well as internationally to numerous countries. The affected batch numbers are identified in the recall notice, with manufacturing dates spanning from 2022 through 2024.

The recalled product

Product
8MM,FORCE BIPOLAR,IS4000 REF 471405
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Instrument
Hazard
  • grip-cable-failure
  • mechanical-failure

Distribution

Distribution scope not specified by the agency.

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