Medtronic Vascular recalls Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm,
Recalled Product
Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 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.
Hazard / Issue
Subsequent failure of catheters in the field and failed quality testing
Issued by
FDA
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