FDA Medical Device Recalls (openFDA)
Cordis Corporation: SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
- Recall number
- Z-0217-2022
- Recalling firm
- Cordis Corporation
- Product
- SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
- Status
- Open, Classified
- Initiated
- 2021-10-01
- Posted
- not on file
- Terminated
- not on file
- Reason
- There is a potential for distal tip dislodgement or separation.
- Root cause
- Process control
- Action
- The firm, Cordis, sent an "Urgent MEDICAL DEVICE RECALL" letter dated 10/1/2021 to its consignees/customers: In the US: The letter and Acknowledgement Form was sent to the following two (2) individuals in each account: Materials Director, and Risk Manager. The delivered letter will be followed up as necessary by phone, until signed Acknowledgement is received, or best effort attempt has occurred. For Affiliate countries: A copy of the letter sent to the affiliates by email. Reconciliation within the country will be performed by the affiliate. A summary statement that the notification is completed is requested of the affiliate. Consignees are asked to do the following: 1) Read the Urgent Medical Device Recall letter. 2) Immediately check your inventory to confirm that you do not have any units from the affected lots in your possession. If you discover that you do have units from the affected lots in your possession, identify and set aside any units from the identified lots in a manner that ensures the affected product will not be used. Check all storage and usage locations. 3) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form or email to: GMB-CordisFieldAction@cardinalhealth.com 4) Return any affected product to the address listed on the form, with reference to your Customer Number, which is listed on the form. 5) Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. Maintain awareness of this notice until all affected product has been returned to Cordis. 6) Keep a copy of this notice with the affected product. For any health care professional with medical concerns, please contact Cordis to speak to a clinician at 1-800-327-7714 Option 1, Monday through F
- Quantity
- 3 units
- Distribution
- US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
- Lot, serial or model codes
- Product Code: SF06120MB; Lot No. 266401
- 510(k) numbers
- ["K121125"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 1016427
- Firm city
- Miami Lakes
- Firm state
- FL
- 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