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

Recalled November 3, 2021 · FDA recall Z-0173-2022 · 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. · FDA Class II

Units

591 units

Sold at

Distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan.

Description

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

Product

C315-HIS Delivery Catheter

Manufacturer(s)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →