Recall Z-0089-2021 ยท DXF Catheter, Septostomy
Medtronic Vascular
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 th
| Date | Oct 16, 2020 (initiated Aug 25, 2020) |
| Status | Terminated |
| Reason | Subsequent failure of catheters in the field and failed quality testing |
| Root cause | Device Design |
| Action | An immediate field corrective action was initiated by Medtronic field representatives. Customers were notified verbally to quarantine and return affected product on 25-Aug-2020. The following information was verbally provided to affected customers by Medtronic representative: "A supplier for Rashkind Catheter product has notified Medtronic that it has shipped product to Medtronic that may contain an issue. The supplier conducts a routine test in production. In two separate lots, the manufacturing specification was not met by all samples, but the lots were inadvertently shipped to Medtronic. W |
| Quantity | 505 units |
| Distribution | Worldwide Distribution: USA (nationwide) states of: MA, PA, TN, IN, MI, WA, CA, CO, AZ, NC; and OUS countries of: Algeria, Armenia, Australia, Austria, Barbados, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hungary, India, Ireland, Israel, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.