Intuitive Surgical Recalls 5mm Curved Cannulae for da Vinci System
Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System due to potential damage during use and to update labeling instructions.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential for damage during use without reporting specific injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Intuitive Surgical, Inc. is recalling 5,217 units of the 5X250 MM Curved Cannula, Arm 1, intended for use with the da Vinci Si Surgical System (model IS3000). The recall is being conducted because the company became aware of the potential for certain lots of these Single-Site 5mm Curved Cannulae to become damaged during use.
The recall action also includes an update to Single-Site labeling. These labeling changes are designed to instruct users on how to inspect the cannulae prior to use and how to appropriately handle them during use. The affected products were distributed worldwide, including in the United States and various countries in Europe, Asia, South America, and the Middle East.
Healthcare providers and facilities using the da Vinci Si Surgical System should check their inventory for the specific part number 428071-03 and the listed lot numbers. Users should follow the updated labeling instructions for inspection and handling to ensure safe use of the device.
The recalled product
- Product
- 5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000)
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 5,217
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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.
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