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# Medtronic Class 1 Recall of Rashkind Balloon Catheters
- URL: https://www.fdaweb.com/medtronic-class-1-recall-of-rashkind-balloon-catheters/
- Published: 2020-11-03T12:00:00.000Z
- Updated: 2026-09-14T16:35:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148006

Medtronic has begun a Class 1 recall of its Rashkind Balloon Septostomy Catheters because of device quality issues that may lead to the device breaking, separating or failing during use. If this occurs, use of the affected product may cause serious injuries, such as damage to blood vessels and death, according to a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-rashkind-balloon-septostomy-catheters-quality-issues?ref=fdaweb.com). The agency says there have been two reported injuries and one death. Additionally, Medtronic has halted the device’s manufacturing and distribution due to “unrelated” reasons, it says. The catheters are used 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.