The Recall Desk

FDA (Devices) recall action 73649

Intuitive Surgical, Inc. recalled 2 products on 2016-04-20

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
2016-04-20
Critical
0
Units
496

Why these products were recalled

Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large Needle Driver Instrument) to manipulate the ablation probes during cardiac surgery can result in an increase of microscopic metallic particulates generated from the contact with the probes.

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.

1–2 of 2

  • HighFDA (Devices)··2016-04-20

    Intuitive Surgical Recalls da Vinci S Surgical System User Manuals

    Intuitive Surgical is recalling da Vinci S Surgical System user manuals because using non-approved instruments with ablation probes may increase microscopic metallic particulates.

    Product
    da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments inclu
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-04-20

    Intuitive Surgical Recalls da Vinci S Surgical System User Manuals

    Intuitive Surgical is recalling da Vinci S Surgical System user manuals because using certain instruments with ablation probes can increase microscopic metallic particulates.

    Product
    da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endosco
    Category
    Distribution
    0 states