Z-2949-2020Class II

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

Name: Z-2949-2020 Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845
Creator: Intuitive Surgical, Inc.
Published: 2020-06-10
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2020-06-10 / Open, Classified / root cause: design

FDA source

Intuitive Surgical, Inc. began a recall of Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845 on 2020-06-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2949-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-06-10
Posted: 2020-09-10
Recalling firm: Intuitive Surgical, Inc.
Product: Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
Product code: EOQ Bronchoscope (Flexible Or Rigid)
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.
Root cause tag: design
FDA 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 [email protected].
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.
Product codes and lots: All lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2949-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2949-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-16	2020-09-10
Z-2950-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-16	2020-09-10

Product code EOQ

K182188Class IIIon Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical / cleared 2019-02-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)