Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: Recalled by Medtronic Inc. Cardiac Rhythm Disease Management Due to Medtronic was notified that Edwards Lifesciences has initiated...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc. Cardiac Rhythm Disease Management directly.
Affected Products
Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
Quantity: 217
Why Was This Recalled?
Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Inc. Cardiac Rhythm Disease Management has 23 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report