The Recall Desk
HighFDA (Devices)·Z-1460-2022·Announced 2022-08-03

Da Vinci Surgical Clip Appliers Recalled for Potential Unexpected Motion

Intuitive Surgical is recalling three models of Da Vinci clip appliers due to potential unexpected motion from partial instrument disengagement. Approximately 90,628 units have been distributed worldwide.

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 FDA Class II recall involves a surgical instrument with potential for unexpected motion due to mechanical disengagement. While no injuries or illnesses are reported in the source, the hazard represents a risk-of-harm to patients during instrument use, meeting the rubric criterion for High severity.

Plain-English summary

Intuitive Surgical, Inc. is recalling Da Vinci X/Xi surgical clip appliers (Large Model 470230, Medium-Large Model 470327, and Small Model 470401) due to the potential for unexpected motion caused by partial disengagement of the instrument from the system.

Approximately 90,628 clip appliers have been distributed worldwide, including throughout the United States and internationally to countries including Canada, Mexico, Japan, Germany, the United Kingdom, Australia, and many others.

Affected parties should contact Intuitive Surgical for instructions regarding the recalled devices. Healthcare facilities should immediately verify whether they have received any of the affected models and follow the manufacturer's guidance.

The recalled product

Product
Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Model 47401
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Instruments
Hazard
  • unexpected-motion
  • instrument-disengagement

Distribution

Distributed nationwide across the United States.

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