Medtronic C304-HIS Device Recall: Sterility Risk in Certain Lots
Medtronic recalls specific lots of C304-HIS devices due to potential sterility compromise from improperly sealed barriers. Affected units may pose infection risks during implant procedures.
Lower-risk recall
The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.
Contact the company
What happened, in plain English
Medtronic is recalling certain lots of C304-HIS cardiac devices because they might have an improperly sealed barrier that could compromise sterility. This risk could lead to infections during implant procedures if the device is used without proper sterilization. Read more at govinfonow.com/recall/60796-medtronic-c304-his-device-recall-sterility-risk-in-certain-lots.
Source Summary by GovInfoNow · govinfonow.com/recall/60796-medtronic-c304-his-device-recall-sterility-risk-in-certain-lots · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1206-2022
Cite this page
“Medtronic C304-HIS Device Recall: Sterility Risk in Certain Lots.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/60796-medtronic-c304-his-device-recall-sterility-risk-in-certain-lots. Based on FDA recall #Z-1206-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1206-2022%22&limit=1).
Why it’s dangerous
The device has a barrier that may not seal properly, potentially allowing contamination during implant procedures. This could lead to infections if the device is not sterilized correctly before use.
Who’s affected
Patients who have received the C304-HIS device during implant procedures and healthcare providers using the device for heart procedures are most at risk. The recall affects specific lot numbers used in certain medical procedures.
How to tell if you have this one
Check for the model number C304-HIS on the device packaging or label. Affected lots include 0010948864, 0010953298, 0010958150, 0010961222, 0010971148, 0011017539, 0011020263, 0011022874, 0011025202, 0011028574, and 0011031177.
- Brand
Medtronic- Product
The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant- Category
Medical device
What to do — step by step
Check Device Lot Number
Look for the lot numbers listed in the recall: 0010948864, 0010953298, 0010958150, 0010961222, 0010971148, 0011017539, 0011020263, 0011022874, 0011025202, 0011028574, 0011031177.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 39 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and the…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the C304-HIS device used for?
The C304-HIS device is used for implant procedures involving cardiac rhythm and heart failure treatment, featuring a guide wire, valve, and deflectable catheter.
Do I need to stop using the device immediately?
The recall does not require immediate stop use; affected devices should be checked for the specific lot numbers listed.
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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-1206-2022 (April 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1206-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.