—#193398

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.

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K183493
Affected lot / code info: Model Number: C304-HIS; GTIN: 00763000147013; Lot Numbers: 0010948864, 0010953298, 0010958150, 0010961222, 0010971148, 0011017539, 0011020263, 0011022874, 0011025202, 0011028574, 0011031177

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Address: 8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

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.

Timeline

Recall initiated: 2022-04-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #193398. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.