FDA Medical Device Recalls (openFDA)
Sorin Group USA, Inc.: Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff is pre-molded to its inflated configuration and is purposely positioned directly over a hole generated in the extruded tube for purposes of receiving the infused cardioplegia solution. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.
- Recall number
- Z-2757-2016
- Recalling firm
- Sorin Group USA, Inc.
- Product
- Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff is pre-molded to its inflated configuration and is purposely positioned directly over a hole generated in the extruded tube for purposes of receiving the infused cardioplegia solution. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.
- Status
- Terminated
- Initiated
- 2016-08-12
- Posted
- 2016-09-08
- Terminated
- 2017-03-27
- Reason
- The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.
- Root cause
- Process control
- Action
- LivaNova issued an Urgent Safety Alert letter via certified mail on August 12, 2016 to all affected customers. The letter instructed customers to check their inventory to determine if the Cannulae belongs to the product code and lots listed. If the customer does not have any of the products described in the communication, please complete the response form below and return it per the instructions indicated on the form; otherwise, please check the tip angle to determine if it is conforming to specifications. If specification is not met, please file a complaint through your normal process whether you decide to keep it and use it or return the product to Sorin Group; if you are not willing to use it, return the affected parts to Sorin Group USA. Please contact Customer Service 1-S00-650-2623 or email CustomerService@livanova.com to have a Return Material Authorization (RMA) issued. Complete the Customer Response Form attached to this letter to acknowledge receipt of this letter. Please return this form no later than September 15, 2016. For questions regarding this recall call 303-467-6306.
- Quantity
- 1205 units worldwide
- Distribution
- Worldwide Distribution - US including IL, MO, TX. Internationally to Canada and Italy.
- Lot, serial or model codes
- Lot Numbers: 1425900137, 1433900079, 1433900080, 1435300088.
- 510(k) numbers
- ["K030231","K972503"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 1718850
- Firm city
- Arvada
- Firm state
- CO
- 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