Z-1206-2022Class II

The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant...

Name: Z-1206-2022 The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant...
Creator: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Published: 2022-04-20
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-04-20 / Open, Classified / root cause: sterility

FDA source

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) began a recall of The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a... on 2022-04-20. FDA classified it as Class II and gives the reason as "The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1206-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-20
Posted: 2022-05-27
Recalling firm: Medtronic, Inc.
Product: The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to remove the deflectable catheter. The deflectable catheter is designed for placement of transvenous devices in or near the bundle of His. It features a deflecting distal section, controlled by the deflectable catheter handle, and an out-of plane curve on the distal tip. The body of the deflectable catheter is radiopaque for visibility on fluoroscopy.
Product code: DQY Catheter, Percutaneous
Reason for recall: The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: The firm sent out a recall notification starting on 04/20/2022 via UPS 2-day delivery. Customers are asked to return all unused affected product, share the notice with all those who need to be aware within their organization or with any organization where the above-listed products have been transferred, and to complete the response form.
Quantity in commerce: 1385 devices
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 countries of Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Poland, Spain, United Arab Emirates, United Kingdom.
Product codes and lots: Model Number: C304-HIS; GTIN: 00763000147013; Lot Numbers: 0010948864, 0010953298, 0010958150, 0010961222, 0010971148, 0011017539, 0011020263, 0011022874, 0011025202, 0011028574, 0011031177

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1206-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1206-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-08	2022-05-27

Product code DQY

K183493Class IISelectSite C304-HIS Deflectable Catheter SystemMedtronic, Inc. / cleared 2019-03-15

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)