The FDA today issued a notice warning of a potential high-risk issue with certain Baxter (NYSE:BAX) Spectrum infusion pump systems. This communication came as part of the FDA’s pilot to enhance its medical device recall program. It follows a letter from Baxter recommending that customers remove certain Spectrum pumps from where they are used or sold. […]
Recalls
Medtronic warns on air pressure issue with certain MiniMed insulin pumps in Europe
Medtronic (NYSE:MDT) issued an urgent field safety notice in Europe related to multiple versions of its MiniMed insulin pump systems. The medtech giant’s notice includes models of the MiniMed 640G, 670G, 720G, 740G, 770G and 780G insulin pumps. During quality testing performed by Medtronic, the company said it recently found that changes in air pressure […]
Dexcom warns of missed G6 receiver alerts in Europe
Dexcom (Nasdaq:DXCM) recently issued an urgent field safety notice in Europe warning of a potential issue with certain G6 receivers. G6 continuous glucose monitor (CGM) receivers deliver glucose readings and alerts. However, certain devices may experience an issue in which alarms/alerts fail to function as designed. In rare instances, the alarm/alert may be missed or […]
Cardinal Health recalls certain insulin syringe component packs
The FDA deemed a recall of Cardinal Health (NYSE:CAH) insulin syringe luer lock packs as type I, the most serious kind of recall. This recall relates to the company’s Monoject U-100 mL insulin syringe luer lock with tip cap soft pack (extended conical tip). The device is used to administer insulin under the skin (subcutaneous) or […]
Medtronic recalls some MiniMed automated insulin delivery systems with battery issues
Medtronic (NYSE:MDT) today announced a voluntary recall warning of battery issues with its MiniMed 600 and 700 series insulin pumps. FDA deemed the recall Class I, the most serious kind. The medtech giant issued a field action starting on July 31, notifying customers to follow built-in alerts for battery status. Customers should contact Medtronic if […]
Smiths Medical warns on infusion cassette reservoirs in Europe
ICU Medical’s Smiths Medical unit issued an urgent field safety notice in Europe to warn of issues with certain medication cassette reservoirs. Smiths Medical’s warning pertains to specific models and lots of its 50 mL and 100 mL CADD medication cassette reservoirs. Certain reservoirs may exhibit a weakened weld joint between the medication bag and […]
ICU Medical recalls some infusion pump batteries, updates instructions
The FDA issued a notice to warn of a recall of ICU Medical (Nasdaq:ICUI) Plum 360 infusion pump system batteries due to a manufacturing defect. ICU Medical designed its Plum 360, Plum A+ and Plum A+3 systems for large-volume fluid infusion. The system delivers blood or blood products, drugs and other fluid mixtures through subcutaneous, […]
Tandem Diabetes Care begins updated software rollout after recall
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it released version 2.8.2 of its Apple iOS t:connect mobile app in the U.S. The company initiated the new software release to remedy issues with prior versions of the technology. Its t:connect mobile app works in conjunction with the t:slim X2 automated insulin pump with Control-IQ technology. Tandem […]
Abbott recalls some FreeStyle Libre 3 sensors in U.S.
Abbott (NYSE:ABT) announced today that it initiated a voluntary recall for a small number of FreeStyle Libre 3 continuous glucose monitor (CGM) sensors. The company distributed the affected sensors during the first half of May 2024. Abbott did not disclose the number of sensors affected but said the recall affects a small subset of FreeStyle […]
Merit Medical recalls certain products containing syringes made in China
Merit Medical issued an urgent medical device recall notice related to specific products that contain plastic syringes made in China. Certain lots of Merit products contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Merit received notice from its supplier indicating that it supplied the company with those syringes. All but one size/type of […]
