Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2022 - (Recall #: Z-1206-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 20, 2022

Date Posted: June 8, 2022

Recall Number: Z-1206-2022

Event ID: 90101

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1385 devices

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated