Recall Z-1206-2022 ยท DQY Catheter, Percutaneous
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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 bund
| Date | Apr 20, 2022 |
| Status | Open, Classified |
| Reason | The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 1385 devices |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183493 | SelectSite C304-HIS Deflectable Catheter System Medtronic, Inc., Mar 15, 2019 |