Medical device companies are working to gain regulatory approvals and launch new catheter-based devices as the world slowly returns to normal after reeling from the COVID-19 pandemic. As of April 19, the FDA had approved 11 medical devices this year — two of them catheter-based. In comparison, the regulatory agency approved 19 devices by April … [Read more...] about 4 catheter-based devices to watch for in 2021
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The worst catheter-based device recalls of 2020
The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA. The agency 2020 tagged a total of 33 medical device recalls as Class I — the most serious level — down from 49 in 2019. The list of the most serious catheter-based device recalls in 2020 includes products from … [Read more...] about The worst catheter-based device recalls of 2020
Teleflex wins FDA clearance for EZ-IO intraosseous vascular access system expanded indications
Teleflex today said it received FDA 510(k) clearance for expanded indications of its Arrow EZ-IO intraosseous vascular access system. The device is designed to be used when intravenous access is difficult or impossible to obtain in emergent, urgent or medically necessary cases. The expanded indication allows the device to be used for up to 48 … [Read more...] about Teleflex wins FDA clearance for EZ-IO intraosseous vascular access system expanded indications
Vascular Solutions recall of Langston dual lumen catheter is Class I
The FDA issued a notice today warning that its recall of the Vascular Solutions Langston dual lumen catheter is identified as Class I, the most serious kind of recall. Vascular Solutions, a Teleflex (NYSE:TFX) subsidiary, designed the Langston dual lumen catheter for the rapid delivery of dye into blood vessels during medical imaging tests, … [Read more...] about Vascular Solutions recall of Langston dual lumen catheter is Class I
Teleflex warns on Arrow multi-lumen catheter
Teleflex (NYSE:TFX) this week initiated a voluntary field safety corrective action in Europe for its Arrow subsidiary's multiple-lumen catheter. In a field safety notice dated March 16, Teleflex announced that Arrow is voluntarily recalling the catheter due to a potential sterility issue. The catheter's product tray may be damaged in affected … [Read more...] about Teleflex warns on Arrow multi-lumen catheter
