The FDA recently labeled a select recall of West Pharmaceutical Services‘ (NYSE:WST) Vial2Bag fluid transfer systems over device functionality issues as Class I. Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences of death. The West Whiteland Township, Penn.-based company’s Vial2Bag […]
FDA warns on air embolism risk with infusion pumps, fluid warmers, rapid infusers
The FDA today released a medical device safety communication warning of air-in-line and air embolism risks, as well as the risks of false alarms for such events, associated with infusion pumps, fluid warmers and rapid infusers. The FDA reinforced the dangers of air-in-line issues, which can lead to potentially life-threatening air embolisms, but also warned […]
Gerresheimer’s Sensile Medical wins CE Mark for infusion pump
Gerresheimer subsidiary Sensile Medical said today it won CE Mark approval in the European Union for its wearable micropump intended for use in the treatment of Parkinson’s disease. The newly cleared device features automatic filling for use with liquid medicines, and includes a color display, charging unit and leather bag which allows the device to be worn […]
DHS warns on BD’s Alaris pump
The U.S. Dept. of Homeland Security issued an advisory this week, warning consumers that BD’s (NYSE: BDX) Alaris syringe pumps can be hacked via a vulnerability that gives a remote attacker unauthorized access to the device when it is connected to a terminal server. BD determined that the affected products are not sold within the U.S., the […]
Baxter wins CE Mark for Evo IQ infusion system
Baxter (NYSE:BAX) said today that its Evo IQ infusion system won CE Mark clearance and regulatory approval in Australia. The company plans to start the launch process for its infusion system in the U.K., Ireland, New Zealand and Australia in the third quarter of this year. Get the full story at our sister site, Drug Delivery […]
Cook Medical touts launch, first use of Advance CS, Compass CT systems
Cook Medical today announced the launch and first use of its Advance CS coronary sinus infusion catheter and Compass CT disposable pressure transducer designed for treating heart failure patients. The CS catheter is a percutaneous balloon infusion catheter designed for use in retrograde coronary sinus infusion procedures to infuse therapeutic agents into the heart via the […]
AcelRx tackles acute pain with sublingual drug-delivery tech
While pain medicine specialist Dr. Pamela Palmer was working at the University of California-San Francisco, she noticed something peculiar was happening to patients undergoing surgery – many who survived their procedures were dying of opioid overdoses as a result of patient-controlled drug pumps. “The nurse has to program a number of parameters into it and, […]
Report: J&J’s Cerenovus to discontinue Codman liver cancer pump
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus is discontinuing production of Codman pumps designed to deliver targeted chemotherapy to the liver for patients with liver cancer, according to a New York Times report. The devices are designed to be implanted in the abdomen to deliver chemotherapy directly to the liver to treat cancer that has spread to […]
Smiths updates recall for Medfusion syringe pumps
Smiths Medical has amended an urgent medical device recall that it first issued in August for its Medfusion syringe pump model series 3500 and 4000. After acknowledging that a defect in certain models of the pump can cause an “invalid syringe size” alarm to go off, the company added an option for facilities with trained staff […]
Spectral Medical wins FDA nod for Spectral Apheresis Machine
Spectral Medical (TSX:EDT) said this month it won FDA 510(k) clearance for its Spectral Apheresis Machine designed for use in continuous renal replacement therapy and therapeutic plasma exchange. The SAM device was developed to support commercialization of the company’s Toraymyxin, or PMX therapy, to enable intensive care units to be able to safely and efficiently deliver […]
CareFusion warns customers about Alaris syringe pump alarm
CareFusion issued a warning to customers of its Alaris syringe drug pump system, cautioning them that pumps made before 2008 may display an error message that could stop the pump from working. The company wrote that it has received a report from a customer that the device displayed a re-occurring internal malfunction error code, PL3, which […]
- 1
- 2
- 3
- …
- 15
- Next Page »
MassDevice Network
@MassDevice
LinkedIn
YouTube