Insulet Omnipod 5 + Abbott Libre 3/Eterna + Dexcom G7 + Tandem + Boston Sci + Medtronic + catheters
Key Questions
What recalls have been issued for Omnipod 5 and related diabetes devices?
Insulet Omnipod 5 has Class I recalls linked to 29 serious adverse events due to tears. Broader recalls include 8000+ EP catheters and issues with Abbott Libre and Dexcom G7 integration.
Which cardiac devices are involved in recent recalls and what are the outcomes?
Boston Scientific ACCOLADE/CRT-P devices are linked to 4 deaths and over 2557 injuries. Medtronic heart devices have one reported death, prompting FDA public warnings.
How have medical device recall numbers changed in Q1 2026?
Overall recalls declined 13% amid FDA QMSR implementation, though sterility-related events remain high. Reports like Dexcom's 14k MAUDE entries continue to surface.
Omnipod Class I tears (29 SAEs); Boston Sci ACCOLADE/CRT-P (4 deaths, 2557+ injuries); Medtronic heart devices (1 death); Dexcom 14k MAUDE; 8000+ EP catheters Class II. Q1 2026 recalls down 13% but sterility high amid FDA QMSR.
Sources (2)
Updated May 24, 2026