Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2021 - (Recall #: Z-0173-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

C315-HIS Delivery Catheter

Product Classification:

Class II

Date Initiated: September 9, 2021

Date Posted: November 3, 2021

Recall Number: Z-0173-2022

Event ID: 88688

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.

Status: Ongoing

Product Quantity: 591 units

Code Information:

GTIN: 00763000160180; Model: C315HIS02 (Serial Number/Lot Number: 0010567341), C315HIS03 (Serial Number/Lot Number: 10568899), and C315HIS04 (Serial Number/Lot Number: 10568900)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated