iRadimed (NSDQ:IRMD) last week finally cleared a five-year-old warning letter from the FDA issued over quality issues with its IV infusion pumps. The August 2014 warning letter chided Winter Springs, Fla.-based Iradimed for its complaint handling and ordered it to seek a new 510(k) clearance for software upgrades to one of the pumps, the mRidium 3860+, […]
ICU Medical recalls infusion sets
ICU Medical (NSDQ:ICUI) said today that it is recalling certain lots of its Plum and Sapphire microbore infusion sets with inline filters due to the potential for small amounts of fluid to leak from the filters’ air vents. San Clemente, Calif.-based ICU Medical said it is not aware of adverse events related to the problem, […]
Report: Medtronic establishes $35m settlement fund for Synchromed pumps
Medtronic (NYSE:MDT) last week reportedly agreed to create a settlement fund worth some $35 million to compensate those who say they were harmed by the SynchroMed II intrathecal drug pump. The settlement involves about 500 people who claimed harm came from use of the pain-fighting pump, represented by three law firms that are negotiating individual […]
B. Braun recalls 2,600 infusion sets
B. Braun Medical is voluntarily recalling one lot of an infusion pump administration set due to the potential for leakage and disconnection. Customers complained about the problems occurring at the bonded joint between the tubing and injection site for the company’s Infusomat space volumetric infusion pump administration sets, according to the Melsungen, Germany-based company. The […]
Eitan Group inks Canadian distribution deal for Sapphire infusion pumps
Eitan Group today announced it signed a distribution agreement with Canadian Hospital Specialities to distribute its Sapphire infusion pumps in Canada. Through the agreement, Canadian Hospital Specialties will supply and support Israel-based Eitan Group’s Sapphire infusion pumps to hospitals and alternate site customers in Canada. Get the full story on our sister site, Drug Delivery Business.
How the Eitan Group aims to disrupt the infusion pump industry
Privately held Eitan Group wants to bring more infusion pumps into people’s homes. Can it compete against the established players? Officials at the Eitan Group want to disrupt the infusion pump market by selling devices that are more connected and software-based — able to be used not only in hospitals but in the home. Eitan is […]
Medtronic lands reimbursement for MiniMed 670G pump in Germany
Medtronic (NYSE:MDT) said today it has secured reimbursement for its MiniMed 670G insulin pump system from regulators in Germany. The German Federal Association of the Statutory Health Insurances (GKV-SV) granted reimbursement for the smart insulin pump for patients with type 1 diabetes, according to the company. Get the full story on our sister site, Drug Delivery […]
Former NFL player may pursue pain pump lawsuit against Stryker, I-Flow
A former NFL player may proceed with a federal lawsuit against Stryker (NYSE:SYK) and I-Flow over a pain pump that the player claims destroyed the cartilage in his shoulder. U.S. District Court Judge Gloria Navarro ruled last week that former New England Patriots linebacker Ryan Claridge could add specifics to his claim that Stryker and […]
Flowonix warns on software anomaly with Prometra pump
Flowonix earlier this month warned about a software anomaly with its Prometra infusion pump that could unexpectedly shut down the device. The Budd Lake, N.J.-based company won FDA approval in February for updated software included in the Prometra system, which is indicated for intrathecal infusion of drug therapy, including infumorph, saline and baclofen. Flowonix warned […]
Eitan taps InfuSystem for Sapphire pump maintenance deal
Eitan Group said today that it inked a deal with InfuSystem (NYSE:INFU) for repair services on its fleet of Sapphire infusion pumps. Madison Heights, Mich.-based InfuSystem plans to offer flat and al-la-carte options for Sapphire service and repair, citing a three-business-day turnaround goal on repairs. Get the full story at our sister site, Drug Delivery […]
Whistleblowers accuse Fla. VA hospital of ignoring Alaris recall
Staff members at a Florida U.S. Veterans Affairs Dept. hospital reportedly said leadership ignored the recall of the Alaris infusion pump made by Becton Dickinson (NYSE:BDX). Leaders at the James Haley Veterans’ Hospital in Tampa dismissed repeated warnings about BD’s device over multiple weeks, even after a patient’s life was endangered, the Military Times reported. […]
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