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 bundle of His. It features a deflecting distal section, controlled by the deflectable catheter handle, a Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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, a
Brand
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Lot Codes / Batch Numbers
Model Number: C304-HIS, GTIN: 00763000147013, Lot Numbers: 0010948864, 0010953298, 0010958150, 0010961222, 0010971148, 0011017539, 0011020263, 0011022874, 0011025202, 0011028574, 0011031177
Products Sold
Model Number: C304-HIS; GTIN: 00763000147013; Lot Numbers: 0010948864, 0010953298, 0010958150, 0010961222, 0010971148, 0011017539, 0011020263, 0011022874, 0011025202, 0011028574, 0011031177
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during th due to The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026