The Recall Desk
HighFDA (Devices)·Z-1459-2022·Announced 2022-08-03

Da Vinci Clip Applier Recall: Risk of Unexpected Instrument Motion

Intuitive Surgical is recalling 62,895 Da Vinci S/Si Clip Appliers worldwide due to potential unexpected motion from partial instrument disengagement. No injuries or illnesses have been reported.

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 an FDA Class II medical device recall involving a risk-of-harm product. No illnesses, injuries, or deaths have been reported. The hazard is a potential risk rather than confirmed actual harm, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Intuitive Surgical, Inc. is recalling three models of Da Vinci S/Si Clip Appliers: the Large Clip Applier (Model 420230), Medium-Large Clip Applier (Model 420327), and Small Clip Applier (Model 420003). These are surgical instruments used with the Da Vinci S/Si surgical robotic system.

The recall was issued due to the potential for unexpected motion caused by partial disengagement of the instrument from the system during use. This creates a risk of harm to patients during surgical procedures.

Approximately 62,895 of these clip appliers have been distributed worldwide, including throughout the United States and to numerous countries globally. The recall affects all serial numbers of the three affected models.

The recalled product

Product
Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Instruments
Hazard
  • instrument-disengagement
  • unexpected-motion

Distribution

Distributed nationwide across the United States.

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