FDA-Device2021-11-03Class II
C315-HIS Delivery Catheter
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
Sold states
Distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan.
Affected count
591 units
Manufactured in
8200 Coral Sea St Ne, N/A, Mounds View, MN, United States
Products
C315-HIS Delivery Catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0173-2022Don't want to check this manually?
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