Insulet Corporation updates on voluntary Medical Device Correction with FDA reporting 476 serious injuries

INSULET CORP

On March 12, 2026, Insulet issued a press release regarding a voluntary Medical Device Correction with 18 Serious Adverse Events reported.
On April 10, 2026, Insulet added 13 expired lots to the correction, stating no impact on previously estimated financial impact.
As of April 17, 2026, FDA reported 476 serious injuries and no deaths associated with the device issue; Insulet clarified these are Medical Device Reports, not confirmed adverse events.
The updated communication on April 10 noted 29 confirmed Serious Adverse Events, up from the initial 18.

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