FDA Medical Device Recalls (openFDA)
Intuitive Surgical, Inc.: ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).
- Recall number
- Z-2950-2020
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).
- Status
- Open, Classified
- Initiated
- 2020-06-10
- Posted
- not on file
- Terminated
- not on file
- 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.
- Root cause
- 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
- 27 units
- Distribution
- U.S.: California, Colorado, Florida, Illinois, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, and Virginia. No foreign consignees.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K182188"]
- PMA numbers
- not on file
- Product code
- EOQ
- Firm FEI
- 3001675293
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28