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 because they may become damaged during use. The recall also includes labeling updates to guide inspection and handling.
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: The recall involves a medical device with a potential for damage during use, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling 5,217 units of the 5X250 MM Curved Cannula, Arm 2, 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 affected products were distributed worldwide, including in the United States and 22 other countries. 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.
Healthcare providers and facilities using the da Vinci Si Surgical System should check their inventory for the specific part number 428072-03 and the listed lot numbers. Users should follow the updated labeling instructions for inspection and handling to ensure safe use of the devices.
The recalled product
- Product
- 5X250 MM Curved Cannula, Arm 2 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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