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.
- Recall Initiated
- April 20, 2022
- Recall Number
- Z-1206-2022
- Quantity
- 1385 devices
- Firm Location
- Mounds View, MN
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.
Lot / Code Info
Model Number: C304-HIS; GTIN: 00763000147013; Lot Numbers: 0010948864, 0010953298, 0010958150, 0010961222, 0010971148, 0011017539, 0011020263, 0011022874, 0011025202, 0011028574, 0011031177
Root Cause
Under Investigation by firm
Action Taken
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.