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Five Medical Device Field Safety Notices Published April 13–17

MHRA published five Field Safety Notices (FSNs) covering the period 13–17 April 2026, affecting five distinct medical devices: Biosense Webster's cardiac irreversible electroporation catheter (09 March 2026), Dexcom's G7 iOS CGM App and Dexcom ONE+ iOS CGM App, Getinge's Stericool sterilant agent (April 2026), The Binding Site Group's EXENT Analyser, and Zimmer's Disposable Mixing Bowls. The notices are published by MHRA for information only; recipients are directed to contact the respective manufacturers directly with questions.

Dexcom EP4318489A2 Patent, Continuous Glucose Monitoring App Compatibility Check

The European Patent Office published patent application EP4318489A2 for Dexcom, Inc. covering a system and method for verifying compatibility of continuous glucose monitoring (CGM) applications. The patent application includes claims related to wireless communication protocols (H04W 4/20), healthcare data management systems (G16H 40/40), and software update mechanisms (G06F 8/65) for medical device applications. The patent is designated across 31 EPO member states including Germany, France, Italy, Spain, and the United Kingdom.

Dexcom G7 iOS CGM App Type II Recall - Display Flicker Issue

Health Canada issued a Type II medical device recall for Dexcom G7 iOS CGM App versions 2.9.0 to 2.11.2 (model SW12300). The affected apps display a flicker that sequentially shows previous Estimated Glucose Values before displaying the current reading. Users are advised to contact Dexcom, Inc. for additional information. The recall was published April 14, 2026, with recall date April 9, 2026.