Teleflex (NYSE: TFX) announced today that the FDA has granted 510(k) clearance for the company's Ringer perfusion balloon catheter for percutaneous transluminal coronary angioplasty (PTCA). The clearance expands Wayne, Pennsylvania–based Teleflex's interventional cardiology portfolio. It enables the company to offer what it says is the only … [Read more...] about Teleflex wins FDA clearance for perfusion balloon for PTCA
teleflex
Teleflex has a serious balloon catheter recall, 3 deaths linked to issue
The FDA says a recall of Teleflex (NYSE:TFX) intra-aortic balloon (IAB) catheter kits is Class I, the most serious kind of recall. Teleflex recalled its Arrow FiberOptix IAB catheter kit and Arrow UltraFlex IAB catheter kit. This recall is a correction, not a product removal. However, the issues related to the kits resulted in reports of 31 … [Read more...] about Teleflex has a serious balloon catheter recall, 3 deaths linked to issue
The worst catheter-based device recalls of 2023
The U.S. saw seven severe catheter-based device recalls in 2023, according to the FDA's medical device recall database. The agency in 2023 tagged 61 medical device recalls as Class I — the most serious level. For comparison, the FDA recalled 60 devices in 2022, of which four were related to catheter-based devices. Last year, the most serious … [Read more...] about The worst catheter-based device recalls of 2023
Teleflex extends Arrow ErgoPack system with hemodialysis, large bore catheters
Teleflex (NYSE:TFX) announced today that it released its Arrow ErgoPack complete kits with hemodialysis and large-bore catheters in the U.S. Wayne, Pennsylvania-based Teleflex launched this update to streamline insertion workflow for clinicians. The company also says it provides more options to suit their particular needs. Clinicians can now … [Read more...] about Teleflex extends Arrow ErgoPack system with hemodialysis, large bore catheters
Teleflex completes enrollment in percutaneous coronary intervention study
Teleflex (NYSE: TFX) announced today that it completed patient enrollment in its prospective multicenter Ringer PTCA study. Ringer PTCA is one of two clinical studies evaluating Teleflex's novel Ringer perfusion balloon catheter. The trial enrolled patients across seven leading complex percutaneous coronary intervention (PCI) centers in the U.S. … [Read more...] about Teleflex completes enrollment in percutaneous coronary intervention study
Teleflex recall of Arrow catheter system is Class I
The FDA today designated Teleflex's recall of its Arrow Endurance extended dwell peripheral catheter system as Class I, the most serious type of medical device recall. The recall involved 262,016 devices distributed from October 26, 2018, to May 10, 2023, according to the FDA. Teleflex and its Arrow International subsidiary have reported 83 … [Read more...] about Teleflex recall of Arrow catheter system is Class I
Teleflex launches two new PICC insertion devices
Teleflex (NYSE:TFX) today announced it launched two new devices to enhance PICC insertion procedures and reduce complications. The company launched the Arrow VPS Rhythm DLX device and the NaviCurve stylet, both of which Teleflex designed to work together to give vascular access specialists more efficient and predictable PICC placement. VPS … [Read more...] about Teleflex launches two new PICC insertion devices
Teleflex launches new injectable midline catheter portfolio
Teleflex (NYSE:TFX) announced today that it released its new Arrow pressure injectable midline portfolio of catheters in North America. Wayne, Pennsylvania-based Teleflex designed its Arrow portfolio to help alleviate line identification confusion. The company said a lack of identification between midlines and catheters creates the potential for … [Read more...] about Teleflex launches new injectable midline catheter portfolio
Teleflex’s central venous access catheters awarded Vizient supply contract
Teleflex today announced it was awarded a contract for the supply of central venous access devices from Vizient, effective immediately. The agreement allows Vizient members to take advantage of special pricing for Teleflex's line of central venous access catheters (CVCs). The group purchasing agreement includes Teleflex's Arrowg+ard Blue Plus … [Read more...] about Teleflex’s central venous access catheters awarded Vizient supply contract
Teleflex launches Arrow pressure catheter in New Zealand
Teleflex this week announced it launched its Arrow Pressure Injectable Midline catheter in Australia and New Zealand. The Wayne, Pennsylvania-based company designed Arrow to help clinicians overcome catheter identification confusion. The regional launch follows last week's announcement of the availability of the catheter in Europe, the Middle … [Read more...] about Teleflex launches Arrow pressure catheter in New Zealand
