FDA (Devices) recall action 85822
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.
One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.
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.
Intuitive Surgical is recalling 67 Ion Catheter Reprocessing Covers because they may fail to engage correctly, potentially causing catheter or system failure.
Intuitive Surgical is recalling 27 units of the ION Reprocessing Accessories Kit because the catheter reprocessing cover may disengage, causing chemical retention and system failure.