The Recall Desk

FDA (Devices) recall action 67758

Intuitive Surgical, Inc. recalled 4 products on 2014-04-16

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2014-04-16
Critical
0
Units
20,868

Why these products were recalled

Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • ModerateFDA (Devices)··2014-04-16

    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.

    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)
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-04-16

    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.

    Product
    5X300 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)
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-04-16

    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.

    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)
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-04-16

    Intuitive Surgical Recalls 5mm Curved Cannulae for Potential Damage

    Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System because they may become damaged during use.

    Product
    5X300 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)
    Category
    Distribution
    0 states