Home / Recalls / Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) / Z-0173-2022

Z-0173-2022 Class II Ongoing

Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Mounds View, MN

FDA device recall Z-0173-2022 was initiated by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) on September 9, 2021 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 591 units.

Recall Details

Product Type: Devices
Report Date: November 3, 2021
Initiation Date: September 9, 2021
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 591 units

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.

Distribution Pattern

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

Code Information

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

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