FDA recall Z-0173-2022

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Class II · device

Product

C315-HIS Delivery Catheter

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2021-09-09
Report date
2021-11-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0173-2022