Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls The C304-HIS device features a guide wire to access the vein
Recalled 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.
Hazard / Issue
The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.
Issued by
FDA
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