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Recall

8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179

Intuitive Surgical, Inc. · 19 Dec 2024

Status
Recall open, classified
Why, in the FDA's words
“Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.”
Recall began
19 Dec 2024
Company
Intuitive Surgical, Inc.
Device type
Robot-assisted surgical systems (computer-controlled instruments) (NAY)
Concerns
K131861, K220023

What it means

A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.

The record

The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.
FDA database