The Recall Desk

FDA (Devices) recall action 74188

Intuitive Surgical, Inc. recalled 2 products on 2016-06-08

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2016-06-08
Critical
0
Units
46,191

Why these products were recalled

Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure.

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

1–2 of 2

  • HighFDA (Devices)··2016-06-08

    Intuitive Surgical Recalls da Vinci Xi Cannula Seals Due to Particulate Risk

    Intuitive Surgical is recalling da Vinci Xi Surgical System cannula seals because particulates could enter the cannula lumen during surgery.

    Product
    SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical System cannula seal is used with the cannula accessory and provides sterile disposable cap for each cannula. When attached to the cannula, the s
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-06-08

    Intuitive Surgical Recalls da Vinci Xi Cannula Seals Due to Particulate Risk

    Intuitive Surgical is recalling da Vinci Xi cannula seals because particulates may enter the cannula lumen during surgery, potentially affecting patients.

    Product
    SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when th
    Category
    Distribution
    1 state