Firm-Wide blog

Medtronic Rashkind Balloon Septostomy Catheter Class 1 Recall

By Burg Simpson
November 4, 2020
2 min read

On November 3, 2020, the FDA issued a Class I recall, the most serious type of recall, for the Medtronic Rashkind Balloon Septostomy Catheter. The catheters are used during surgery to create an atrial septal defect or to enlarge an existing atrial septal defect as a treatment option for patients with cyanotic congenital heart defects.

In September 2020, Medtronic issued a letter to health care professionals about the recall of all Rashkind Balloon Septostomy Catheters. The FDA recall explains Medtronic issued the recall due to device quality issues which may lead to device the breaking, separating or failing during use.  If this occurs, the catheter may cause damage to blood vessels and even death.  The Medtronic letter details nine complaints involving balloon integrity and subsequent failure that involved one patient death and a serious embolization in one patient.

For more information on the FDA recall, click here. To review the Medtronic recall letter, including the list of the recalled devices, click here.

If you or a loved one suffered injuries you believe were caused by the recalled Medtronic Rashkind Balloon Septostomy Catheters, contact the nationally recognized product liability attorneys in Burg Simpson’s Cincinnati, Ohio office today. They can be reached by phone at (513) 852-5600 or through their website.


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