Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
C315-HIS Delivery Catheter Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Due to Medtronic is recalling three lots of unused C315HIS...
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 and Heart Failure (CRHF) directly.
Affected Products
C315-HIS Delivery Catheter
Quantity: 591 units
Why Was This Recalled?
Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
Where Was This Sold?
Distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan.
About Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 198 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report