Lower risk Medical device recall · FDA · Published September 9, 2021

Medtronic C315HIS Delivery Catheter Recall: Inability to Pass Lead

Medtronic recalls unused C315HIS Delivery Catheters (lots 0010567341, 10568899, 10568900) due to inability to pass a lead through the catheter. Affected users should contact Medtronic for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0173-2022Medical device Medtronic ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)8200 Coral Sea St Ne · Mounds View, MN 55112-4391

✎ GovInfoNow plain-language explainer

Medtronic is recalling three specific lots of unused C315HIS Delivery Catheters because they may not allow a lead to pass through. This could prevent proper medical treatment during heart procedures. Read more at govinfonow.com/recall/61815-medtronic-c315his-delivery-catheter-recall-inability-to-pass-lead.

Source Summary by GovInfoNow · govinfonow.com/recall/61815-medtronic-c315his-delivery-catheter-recall-inability-to-pass-lead · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0173-2022

Cite this page

“Medtronic C315HIS Delivery Catheter Recall: Inability to Pass Lead.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61815-medtronic-c315his-delivery-catheter-recall-inability-to-pass-lead. Based on FDA recall #Z-0173-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0173-2022%22&limit=1).

The FDA announced on 2021-09-09 that Medtronic Inc. is voluntarily recalling three lots of unused C315-HIS Delivery Catheters due to reports of an inability to pass a lead through the device, according to the FDA.

How to tell if you have it

C315-HIS Delivery Catheter
GTIN: 00763000160180
Model: C315HIS02 (Serial Number/Lot Number: 0010567341)
Model: C315HIS03 (Serial Number/Lot Number: 10568899)
Model: C315HIS04 (Serial Number/Lot Number: 10568900)

The hazard

Medtronic is recalling the catheters due to reports of an inability to pass a lead through the device, according to the FDA.

Context

GovInfoNow's records show Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 29 other recalls on record since 2017-12-19. Other recent recalls of similar products include Medtronic ICDs with specific model number may have reduced energy output during high voltage therapy (2023-05-10), Medtronic - Cardiac Rhythm and Heart Failure (CRHF) Devices (2022-06-22), Medtronic C304-HIS Device Recall: Sterility Risk in Certain Lots (2022-04-20), Medline Medical Procedure Kits Recall: Catheter Issues (2026-05-04), Medline Oral Restoration Kits Recall: Catheter Issues (2026-05-04), and Stryker Medtronic Marinr Steerable Catheter Recall: Incomplete Sterile Seals (2026-04-10).

How to tell if you have this one

Check your catheter's serial number or lot number. The affected models are C315HIS02 (lot 0010567341), C315HIS03 (lot 10568899), and C315HIS04 (lot 10568900).

Brand
Medtronic
Product
C315-HIS Delivery Catheter
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Your Catheter Details
Look for the serial number or lot number on your catheter to see if it matches the recalled models.

How this recall unfolded

Recall timeline

FDA published this recall 55 days after the firm started it.

Sep 9, 2021Firm started the recall
Oct 22, 2021FDA classified it Class II
Nov 3, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have this catheter?

Contact Medtronic directly to confirm if your catheter is affected and get instructions on next steps.

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Link to this recall

<a href="https://govinfonow.com/recall/61815-medtronic-c315his-delivery-catheter-recall-inability-to-pass-lead">Medtronic C315HIS Delivery Catheter Recall: Inability to Pass Lead (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0173-2022 (September 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0173-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.