The Recall Desk
HighFDA (Devices)·Z-0702-2022·Announced 2022-03-09

da Vinci Surgical Cannula Reducer Metal Tip May Dislodge During Surgery

Intuitive Surgical is recalling the da Vinci Xi and X 12-8 mm Conductive Cannula Reducer because the metal tip may dislodge from the plastic shaft. If unnoticed, additional surgery may be needed, or energy leakage could cause tissue damage.

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 recall involving potential for serious harm including tissue damage from energy leakage and bowel obstruction from retained foreign material. However, no illnesses or injuries have been reported, and the hazards remain theoretical or potential rather than confirmed. Per the severity rubric, the presence of potential risk-of-harm without reported injury places this at the High severity level.

Plain-English summary

Intuitive Surgical, Inc. is recalling the da Vinci Xi and X 12-8 mm Conductive Cannula Reducer (Model REF: 470381-11) worldwide. The recall affects approximately 149,646 units that were distributed globally, including across all 50 U.S. states and numerous international markets.

The metal tip of the reducer may become dislodged from the plastic shaft. This defect poses multiple risks: if the dislodgement goes undetected during surgery, additional surgery may be required to remove the metal tip. If the procedure continues without the metal tip, there is potential for energy leakage, which could cause tissue damage. If the metal tip remains in the patient, adhesions may form, which could lead to bowel obstruction and chronic abdominal pain.

Patients who have received this device as part of a da Vinci robotic surgical procedure should contact their healthcare provider if they experience complications following their surgery. Healthcare providers using this device should review the affected lot numbers and contact Intuitive Surgical for further guidance.

The recalled product

Product
da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical / Robotic Surgery
Hazard
Affected units
149,646

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

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