The Recall Desk

FDA (Devices) recall action 70467

Intuitive Surgical, Inc. recalled 2 products on 2015-03-04

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
2015-03-04
Critical
0
Units
6,564

Why these products were recalled

Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws.

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

  • ModerateFDA (Devices)··2015-03-04

    Intuitive Surgical Recalls EndoWrist Vessel Sealers Due to Grip Interference

    Intuitive Surgical is recalling 3,282 EndoWrist One Vessel Sealers because manufacturing variability may cause interference in the instrument grips.

    Product
    EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator. It is i
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2015-03-04

    Intuitive Surgical Recalls EndoWrist Vessel Sealers Due to Grip Interference

    Intuitive Surgical is recalling EndoWrist One Vessel Sealers because manufacturing variability may cause interference in the instrument grips.

    Product
    EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It
    Category
    Distribution
    1 state