Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure,

Recalled June 8, 2022 · FDA recall Z-1206-2022 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Hazard

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

Units

1385 devices

Sold at

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.

Description

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

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.

Manufacturer(s)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →