Health Canada — Medical Devices · Canada · 2024-05-03 · Type I
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Reported risk: Medtronic has received complaints of ES-330 catheters measuring diameters that are significantly (more than 50%) lower than actual. The failure mode may be reported as "failed precheck", "incorrect distensibility reading", "no distensibility value displayed", "adverse event without identified device or use problem", or "diameter incorrect." Medtronic Lafayette returned product analysis lab testing of unused, returned ES-330 catheters showed saline conductivity that is approximately 10 times lower than specification. The ES-330 saline conductivity specification is 2.25 mS/cm. The saline conductivity of multiple unused, returned ES-330 catheters had saline conductivity at or near 0.25 mS/cm. Recall start date: April 25, 2024
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