Medtronic Vascular - Rashkind Balloon Septostomy Catheter - Class 1 Recall
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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2020 Category: Medical Devices Source Type: alerts

Medtronic Vascular - Rashkind Balloon Septostomy Catheter - Class 1 Recall
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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2020 Category: Medical Devices Source Type: alerts

Medtronic Vascular - Rashkind Balloon Septostomy Catheter - Class 1 Recall
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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2020 Category: Medical Devices Source Type: alerts

Baylis Medical Corp * - NRG Transseptal Needle and NRG RF Transseptal Kit - Class 2 Recall
NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF-71-C0. The NRG Transseptal Needle is packaged onto a thermoformed tray with two lids, which is individually packaged in a Tyvek/nylon pouch. Used to create an atrial septal defect in the heart. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 11, 2016 Category: Medical Equipment Source Type: alerts

St Jude Medical Inc - AMPLATZER TorqVue FX Delivery System - Class 1 Recall
AMPLATZER¿ TorqVue¿ FX Delivery System, Rx Only, Sterilized using ethylene oxide, AGA Medical corporation, 5050 Nathan Lane North, Plymouth, MN 55442. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80 9-ITVFX12F45/80, 9-ITVFX13F45/80. Used to close atrial septal defects between the right and left atriums. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 12, 2013 Category: Medical Equipment Source Type: alerts