Recall Z-0088-2021— Medtronic Vascular
Class I · Terminated
Class I FDA medical device recall by Medtronic Vascular, initiated 2020-08-25, terminated 2024-04-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 00613994760265 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.. Reason: Subsequent failure of catheters in the field and failed quality testing.
- Recalling firm
- Medtronic Vascular
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2020-08-25
- Terminated
- 2024-04-04
- Firm location
- Danvers, MA, United States
Product description
Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 00613994760265 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.
Reason for recall
Subsequent failure of catheters in the field and failed quality testing
Data sourced from openFDA. This site is unofficial and independent of the FDA.