FDA Medical Device Recalls (openFDA)
Medtronic Inc. Cardiac Rhythm Disease Management: Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified by the user. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures.
- Recall number
- Z-1000-2014
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- Product
- Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified by the user. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures.
- Status
- Terminated
- Initiated
- 2014-01-30
- Posted
- 2014-02-20
- Terminated
- 2014-10-06
- Reason
- Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.
- Root cause
- Under Investigation by firm
- Action
- The firm, Medtronic, sent an "Urgent Medical Device Recall" letter dated January, 2014 via UPS on January 30, 2014 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify and quarantine all listed product in your inventory; return all listed product to Medtronic and contact Customer Service at 800 854-3570 and reference RADAR #167826 to initiate a return and credit of product; complete and return the attached Customer Confirmation Certificate via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality, and share this notification with others in your organization as appropriate. Select 3D and Select CAP Arterial Cannula are not available for purchase at this time. Please contact your Medtronic sales representative or Medtronic LifeLine Technical Services at 1 877-526-7890 or (+1 763) 526-7890 to assist with alternative cannula selection and any additional questions you may have related to this notification.
- Quantity
- 19483 total (7669 US, 11814 OUS)
- Distribution
- Worldwide distribution: US (Nationwide) including Puerto Rico, and Internationally to: Algeria, Argentina, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Cyprus, El Salvador, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Jordan, Kuwait, Netherlands, Oman, Paraguay, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela, and Yemen.
- Lot, serial or model codes
- Model 3Y90R3, Lot numbers: 12227513, 12277464, 206420618, 206618641, 206842458, 206932996, 207184816. Model C300901B, Lot number 206499164.
- 510(k) numbers
- ["K800178"]
- PMA numbers
- not on file
- Product code
- DWE
- Firm FEI
- 2182208
- Firm city
- Saint Paul
- Firm state
- MN
- 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