—#181839

Product

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

FDA product code: EOQ — Bronchoscope (Flexible Or Rigid)
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K182188
Affected lot / code info: All lots.

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

The firm notified their consignees regarding the "Urgent Medical Device Recall" notification via Fedex, and issued on 06/10/2020. The actions to be taken by the Customer/User are as follows: Locate the affected product at the site and return to the recalling firm via the standard RMA process. As part of the standard field action process, please take the following actions: 1. Inform necessary hospital personnel about this issue. 2. Inform necessary personnel when corrective action has been completed. 3. Complete the Acknowledgement Form and return to the recalling firm as instructed on the form. 4. Please retain a copy of letter and Acknowledgement Form for reference. Actions to be taken by the recalling firm: 1. A firm representative will make contact to support in replacing the affected product. 2. The firm will promptly overnight replacement product (PN 490118) after Customer Service is contacted by phone and receives the number of affected Catheter Reprocessing Covers (PN 490114-02) at the hospital. If further information is needed or support concerning the Medical Device Recall, contact your Sales Representative or contact Customer Service at the number listed below: Customer Support: 1-866-225-2071, Option 3 (7 AM to 5 PM EST) or Customerservice@intusurg.com.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 101, Sunnyvale, California 94086-5304

Distribution

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

Timeline

Recall initiated: 2020-06-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181839. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.