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Class I Recall Issued by FDA for J&J Heart Device Used for Patients of Cardiac Catheterization

On Tuesday, December 3, the United States Food & Drug Administration announced a Class I recall of a Johnson & Johnson Sterilmed Reprocessed Agilis Steerable Introducer Sheath. This device is used by medical professionals to insert and position a cardiovascular catheter into the heart. These catheters are used to test patients who are believed to have or are susceptible to heart diseases. While placement of these catheters are usually low-risk procedures, the Johnson & Johnson Sterilmed Reprocessed Agilis Steerable Introducer Sheath has been denoted as a Class I recall. This means the device is capable of causing serious injury or fatality in patients who undergo the procedure with the use of this specific mechanism to place the catheter.

The issue with the device is its incorporated hemostatic valve. This valve is designed to prevent a person’s blood from inversely flowing back through the valve. The FDA has stated that the valves may fail due to an improper seal of the sheath hub. This failure can result in the cap of the device falling off of the mechanism or it can create a pressure difference that could end in a case of “air embolism.”

The seal’s failure is reportedly a result of a lack of glue that holds the cap to the hub after reprocessing.

Patients who have undergone cardiac catheterization through this use of this device are susceptible to air embolism, which is a medical condition where air bubbles block the blood’s passage to vital organs.

Symptoms of this complication include the following:

  • Breathing troubles
  • Chest pain
  • Stroke
  • Low blood pressure
  • Confusion

If not treated properly, this condition can result in fatality.

If you or a loved one have recently undergone a cardiac catheterization, it is dire that you contact your medical specialist right way to decipher if your procedure was performed using the faulty device. Time is of the essence, so contact your doctor now. In the event you have received medical complications that resulted from the Johnson & Johnson device, it is advisable you seek a legal professional immediately. Our medical device injury attorneys are ready to help you receive the compensation you deserve.

Call (888) 493-1629 for immediate legal consultation at no cost to you.