Boston Scientific (NYSE:BSX) has issued an urgent field safety notice in Europe due to potential issues with its SpaceOAR systems. Marlborough, Massachusetts-based Boston Scientific’s SpaceOAR system is an absorbable polyethylene glycol hydrogel spacer for separating the prostate from the rectal wall during radiation treatment for prostate cancer. The SpaceOAR Vue, the next-generation hydrogel spacer, offers enhanced […]
Recalls
Tandem Diabetes warns on some t:slim X2 insulin pumps
Tandem Diabetes Care (Nasdaq:TNDM) issued an urgent field safety notice in Europe for its t:slim X2 insulin pump with Basal-IQ technology. The notice, dated February 2022, alerts users of Tandem’s insulin pump with a software version of 6.3.0.1 that there may be a potential safety risk when using the pump within its normal specifications. Tandem’s […]
Fresenius Kabi recalls sodium acetate injection due to presence of particulate matter
Fresenius Kabi USA announced today that it initiated the voluntary recall of seven lots of its sodium acetate injection. Lake Zurich, Illinois-based Fresenius Kabi recalled the USP, 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial to the user level due to the presence of particulate matter found in reserve and/or […]
Baxter warns of alarm malfunction on some infusion pumps
Baxter (NYSE:BAX) announced today that it has issued an urgent safety communication regarding upstream occlusion alarms for certain infusion pumps. Deerfield, Illinois–based Baxter warned that incorrect administration set setup and/or the incomplete resolution of upstream occlusion alarms may result in reduced delivery or non-delivery of medication. The problem might occur without the users receiving alerts […]
Medtronic Diabetes receives FDA warning over quality system requirement inadequacies
Medtronic (NYSE:MDT) announced today that it received an FDA warning letter after an inspection of its Diabetes Business. The company received the letter on Dec. 9 for its Northridge, California facility — the Medtronic Diabetes Business headquarters — following an inspection that concluded in July 2021. FDA’s warning letter to Medtronic focused on the inadequacy […]
Medtronic facing class action suit from Canada MiniMed insulin pump users
A national class action in Canada has been commenced against Medtronic (NYSE:MDT) over its MiniMed 630G and 670G insulin pumps. Rochon Genova and Cardill Law commenced the proposed class action suit against Medtronic, Medtronic MiniMed and Medtronic of Canada over the insulin pumps approved for use in the country in 2016 and 2018. The pumps […]
BREAKING: Medtronic expands Class I recall of MiniMed 600 series insulin pumps
The FDA today announced that Medtronic (NYSE:MDT) has expanded the Class I recall of its MiniMed 600 series insulin pumps. Medtronic today notified customers by email and phone that the recall has been expanded to replace all MiniMed 600 series insulin pumps that contain the clear container ring. The Fridley, Minnesota-based company first warned of […]
Baxter working on software upgrade for serious Spectrum IQ problems
Baxter (NYSE:BAX) this week issued an urgent medical device correction for all of its Spectrum IQ infusion pumps. Earlier this month, FDA designated a recall of Baxter’s Dose IQ safety software program as Class I, its most serious level. Baxter designed the Dose IQ as a standalone computer-based software program that allows care providers to […]
Cardinal Health recalls some saline syringes due to air embolism risk
Cardinal Health (NYSE:CAH) has initiated a U.S. recall of its Monoject Flush prefilled saline syringes due to an issue with the reintroduction of air. Dublin, Ohio-based Cardinal Health on Aug. 4 recalled approximately 267 million Monoject Flush devices because they have been found to reintroduce air into the syringe after the air has been expelled, […]
Baxter has a serious recall involving infusion pump software
The FDA issued a Class I recall — the most serious kind of recall — for Baxter’s Dose IQ safety software program. Baxter designed its Dose IQ safety software as a standalone computer-based software program that allows care providers to create a drug library of pre-programmed dosing information for specific medications, which are delivered into […]
