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
Regulatory
FDA hits Olympus with warning letters after factory inspections
The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their endoscope and reprocessor manufacturing facilities. The warning letters allege medical device reporting (MDR) and quality system violations at the manufacturing operations. “Olympus’ highest … [Read more...] about FDA hits Olympus with warning letters after factory inspections
The top 10 catheter innovation news stories of 2022
This year was a big one for catheter innovation as medtech companies large and small received regulatory approvals and researchers developed catheters that could soon make navigating the vasculature system easier. The numerous innovations weren't just limited to adults. One company launched a cryoablation catheter for children as young as 2 … [Read more...] about The top 10 catheter innovation news stories of 2022
MedAlliance’s Selution SLR wins FDA IDE approval for in-stent restenosis
MedAlliance today announced it received FDA investigational device exemption (IDE) approval for its Selution SLR to initiate its coronary pivotal clinical trial for in-stent restenosis. Geneva-based MedAlliance's Selution SLR is a drug-eluting balloon that is indicated for below-the-knee and superficial femoral artery (SFA) indications, for … [Read more...] about MedAlliance’s Selution SLR wins FDA IDE approval for in-stent restenosis
Fujifilm wins FDA clearance for endoscopic ultrasound scope with Arietta 850 processor
Fujifilm recently announced it received FDA 510(k) clearance for its EG-740UT1 linear endoscopic ultrasound scope that is compatible with its Arietta 8502 ultrasound processor. The company designed EG-740UT for diagnostic and therapeutic endoscopic ultrasound procedures in the upper digestive tract, including the esophagus, stomach and duodenum. … [Read more...] about Fujifilm wins FDA clearance for endoscopic ultrasound scope with Arietta 850 processor
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
