Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Rashkind Balloon Septostomy Catheter Recalled by Medtronic Vascular Due to Subsequent failure of catheters in the field and...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Vascular directly.
Affected Products
Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613994760289 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality.
Quantity: 2356 units
Why Was This Recalled?
Subsequent failure of catheters in the field and failed quality testing
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Vascular
Medtronic Vascular has 211 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report