Skip to content
Recall Observatory FDA recall evidence

Device product

Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.

Z-2949-2020

June 10, 2020

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 85822
Status
Ongoing
Classification
Class II
Quantity
67 units
Official record key
device-enforcement:Z-2949-2020

Official wording

Reason: 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.

Code information: All lots.

Distribution pattern: U.S.: California, Colorado, Florida, Illinois, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, and Virginia. No foreign consignees.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.