The Recall Desk

FDA (Devices) recall action 74705

Intuitive Surgical, Inc. recalled 3 products on 2016-08-17

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2016-08-17
Critical
0
Units
6,195

Why these products were recalled

An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend

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.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2016-08-17

    Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments

    Intuitive Surgical is recalling da Vinci EndoWrist Stapler 30 instruments and reloads due to an increased trend of 'Stapler Firing Failed' messages.

    Product
    STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-08-17

    Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments

    Intuitive Surgical is recalling da Vinci EndoWrist Stapler 30 instruments and reloads due to an increased trend of firing failures.

    Product
    CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-08-17

    Intuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Firing Failures

    Intuitive Surgical is recalling da Vinci EndoWrist Stapler 45 devices due to an increased trend of stapler firing failures.

    Product
    STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection…
    Category
    Distribution
    1 state