The FDA this week said the Medtronic (NYSE:MDT) recall of some Mahurkar hemodialysis catheters is Class I, the most serious kind. Medtronic is recalling its Mahurkar acute dual lumen high flow 13.5 Fr hemodialysis catheters, also known as Mahurkar QPlus, due to reports of a potential catheter hub defect that could cause leaks in a catheter's … [Read more...] about FDA labels Medtronic recall of some Mahurkar hemodialysis catheters as Class I
Recalls
BD issues urgent field safety notice for Venovo venous stent system
BD has issued an urgent field safety notice for its Venovo venous stent system. The notice out of Germany warns of potential delayed deployment and silicone embolization if the proximal end of the Venovo venous stent system does not immediately expand upon deployment and remains connected to the stent cushion on the delivery system. According … [Read more...] about BD issues urgent field safety notice for Venovo venous stent system
FDA labels Medtronic recall of some endotracheal tubes as Class I
The FDA this week said the Medtronic recall of some NIM Contact Reinforced EMG endotracheal tubes is Class I, the most serious kind. Medtronic is recalling its NIM Contact Reinforced EMG endotracheal tubes and NIM Standard Reinforced EMG endotracheal tubes due to reports of obstruction of the endotracheal tube while in use in patients. Tube … [Read more...] about FDA labels Medtronic recall of some endotracheal tubes as Class I
LeMaitre Vascular warns on some Syntel Silicone over-the-wire embolectomy catheters
LeMaitre Vascular (NSDQ:LMAT) recently issued an urgent field safety notice for some of its Syntel Silicone over-the-wire embolectomy catheters. The Burlington, Massachusetts-based company issued the warning due to the French size next to the outside diameter symbol on the label not reflecting the 5 Fr catheter extrusion used on all models of … [Read more...] about LeMaitre Vascular warns on some Syntel Silicone over-the-wire embolectomy catheters
Gore voluntarily recalls some balloon catheters
W.L. Gore and Associates recently announced the voluntary product recall of its Molding and Occlusion Balloon (MOB) Catheters. The Newark, Delaware-based manufacturing company issued the warning due to complaints of leakage from the guidewire lumen and the y-hub during the preparation or use of the MOB catheters. The issue could result in … [Read more...] about Gore voluntarily recalls some balloon catheters
