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U.S. Department of Health and Human Services

Class 2 Device Recall Ion Endoluminal System

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  Class 2 Device Recall Ion Endoluminal System see related information
Date Initiated by Firm June 10, 2020
Create Date September 10, 2020
Recall Status1 Open3, Classified
Recall Number Z-2949-2020
Recall Event ID 85822
510(K)Number K182188  
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
Product Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
Code Information All lots.
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 101
Sunnyvale CA 94086-5304
For Additional Information Contact
408-523-2100
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 67 units
Distribution U.S.: California, Colorado, Florida, Illinois, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, and Virginia. No foreign consignees.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = EOQ and Original Applicant = Intuitive Surgical
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