FDA-Device2014-02-26Class II
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.
Medtronic Inc. Cardiac Rhythm Disease Management
Hazard
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.
Sold states
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.
Affected count
19483 total (7669 US, 11814 OUS)
Manufactured in
8200 Coral Sea St NE, Saint Paul, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1000-2014Don't want to check this manually?
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