The Recall Desk
HighFDA (Devices)·Z-0868-2025·Announced 2025-01-22

Intuitive Surgical Bipolar Dissectors Recalled for Frayed Grip Cables

Intuitive Surgical is recalling 141 curved bipolar dissectors due to complaints of frayed or broken grip cables on the 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 a Class II medical device recall involving mechanical failure of a reusable surgical instrument. Although no injuries or illnesses have been reported, frayed or broken grip cables on a surgical instrument present a potential risk-of-harm, meeting the criteria for a High severity rating.

Plain-English summary

Intuitive Surgical, Inc. is recalling 141 units of the 8MM Curved Bipolar Dissector, Model IS4000 (Reference 470344), a reusable surgical instrument. The recall was initiated due to increased complaints regarding frayed or broken grip cables on these instruments with jaws.

The affected units were distributed nationwide across all U.S. states and territories, as well as internationally to more than 40 countries.

The recalled product

Product
8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
141

Distribution

Distributed in 52 states:

Part of a larger recall action

This product is one of 37 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 37 products in this recall →

Related recalls

Same manufacturer · Intuitive Surgical, Inc.

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Same hazard · cable failure

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