Home / Recalls / Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) / Z-1206-2022

Z-1206-2022 Class II Ongoing

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

FDA device recall Z-1206-2022 was initiated by Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) on Apr 20, 2022 and is designated Class II. Reason for recall: The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility. The recall status is ongoing. Affected quantity: 1385 devices.

Recall Details

Product Type: Devices
Report Date: Jun 8, 2022
Initiation Date: Apr 20, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1385 devices

Product Description

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.

Reason for Recall

The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.

Distribution Pattern

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.

Code Information

Model Number: C304-HIS; GTIN: 00763000147013; Lot Numbers: 0010948864, 0010953298, 0010958150, 0010961222, 0010971148, 0011017539, 0011020263, 0011022874, 0011025202, 0011028574, 0011031177

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1206-2022
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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