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

Is my product affected?

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 cat

• UPC 00763000147013

Check against the official notice below — it lists the full affected range.

What happened

Medtronic Inc. is recalling 1,385 units of its C304-HIS cardiac device, which includes a guide wire, valve, and deflectable catheter used during heart implant procedures. The company identified through internal testing that certain lots may have an improperly sealed barrier that could compromise the device's sterility. The affected devices were distributed worldwide, including across all U.S. states and multiple European countries, with specific lot numbers ranging from 0010948864 to 0011031177.

The recall notice does not specify a remedy or course of action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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. Quantity: 1385 devices Lot/code info: Model Number: C304-HIS; GTIN: 00763000147013; Lot Numbers: 0010948864, 0010953298, 0010958150, 0010961222, 0010971148, 0011017539, 0011020263, 0011022874, 0011025202, 0011028574, 0011031177

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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