# FDA recall Z-1206-2022

> **Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)** · Class II · device recall initiated 2022-04-20.

## 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.

## Reason for recall

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

## 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.

## Key facts

- **Recall number:** Z-1206-2022
- **Recalling firm:** Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-20
- **Report date:** 2022-06-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mounds View, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1206-2022

## Citation

> AI Analytics. FDA recall Z-1206-2022. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1206-2022. Source: US FDA. Licensed CC0.

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