The Recall Desk

FDA (Devices) recall action 86381

Medtronic Vascular recalled 3 products on 2020-10-28

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2020-10-28
Critical
0
Units
3,572

Why these products were recalled

Subsequent failure of catheters in the field and failed quality testing

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2020-10-28

    Medtronic Vascular Recalls Rashkind Balloon Septostomy Catheters Due to Field Failures

    Medtronic Vascular is recalling 505 units of Rashkind Balloon Septostomy Catheters due to subsequent field failures and failed quality testing.

    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 tre
    Category
    Distribution
    10 states
  • HighFDA (Devices)··2020-10-28

    Medtronic Rashkind Balloon Septostomy Catheter Recall for Quality Failures

    Medtronic Vascular is recalling Rashkind Balloon Septostomy Catheters due to field failures and failed quality testing. The recall covers 2,356 units distributed worldwide.

    Product
    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
    Category
    Distribution
    10 states
  • SevereFDA (Devices)··2020-10-28

    Medtronic Recalls Rashkind Balloon Septostomy Catheters Due to Field Failures

    Medtronic Vascular is recalling 711 units of Rashkind Balloon Septostomy Catheters due to subsequent field failures and failed quality testing.

    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 tre
    Category
    Distribution
    10 states