Intuitive Surgical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2949-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 10, 2020

Date Posted: September 16, 2020

Recall Number: Z-2949-2020

Event ID: 85822

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 67 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated