Recall Z-0173-2022— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Name: FDA recall Z-0173-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-09

Class II · Ongoing

Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2021-09-09. It names one FDA 510(k) clearance: K101885. Product: C315-HIS Delivery Catheter. Reason: Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter..

Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Classification: Class II
Status: Ongoing
Initiated: 2021-09-09
Firm location: Mounds View, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K101885 — MEDTRONIC C315 DELIVERY CATHETERMedtronic, Inc.·cleared 2010-09-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.