Z-0173-2022Class II

C315-HIS Delivery Catheter

Name: Z-0173-2022 C315-HIS Delivery Catheter
Creator: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Published: 2021-09-09
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-09-09 / Open, Classified

FDA source

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) began a recall of C315-HIS Delivery Catheter on 2021-09-09. FDA classified it as Class II and gives the reason as "Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0173-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-09
Posted: 2021-10-22
Recalling firm: Medtronic, Inc.
Product: C315-HIS Delivery Catheter
Product code: DQY Catheter, Percutaneous
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.
FDA root cause: Under Investigation by firm
Action: Written notification letter titled, "MEDICAL DEVICE RECALL C315HIS DELIVERY CATHETER" was sent to all consignees on 09/09/2021 via 2-day UPS delivery. The letter instructs the consignee to take the following actions: "Check your inventory for the catheters identified in Table 1 above. If the product has been consumed, please complete the enclosed Customer Confirmation Form and email to [email protected]. No further actions are required. " If there is unused identified product in your inventory, quarantine and return it to Medtronic. Contact Medtronic Customer Service at xxxxxxx to initiate a product return. Your local Medtronic Representative can assist you in the return of this product. o Note: Root cause is under investigation for this issue. Return of the identified product will aid the investigation. Please complete the enclosed Customer Confirmation Form and email to [email protected]." The letter also instructs the consignee to share the notice with all those who need to be made aware with their organization or to any organization where the potentially affected products have been transferred.
Quantity in commerce: 591 units
Distribution: Distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan.
Product codes and lots: GTIN: 00763000160180; Model: C315HIS02 (Serial Number/Lot Number: 0010567341), C315HIS03 (Serial Number/Lot Number: 10568899), and C315HIS04 (Serial Number/Lot Number: 10568900)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0173-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0173-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-03	2021-10-22

Product code DQY

K101885Class IIMedtronic C315 Delivery CatheterMedtronic, Inc. / cleared 2010-09-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)