medical Class II Updated 2021-11-03

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls C315-HIS Delivery Catheter

Recalled Product

C315-HIS Delivery Catheter


Hazard / Issue

Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.

Issued by

FDA

Distribution: Distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan.
Lot/Code Info: GTIN: 00763000160180; Model: C315HIS02 (Serial Number/Lot Number: 0010567341), C315HIS03 (Serial Number/Lot Number: 10568899), and C315HIS04 (Serial Number/Lot Number: 10568900)
View official government recall

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