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Esoflip dilation catheter 30mm
Official notice
3 May 2024
Last checked
3 May 2024
An official Health Canada notice concerns Esoflip dilation catheter 30mm. 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 Published 2024-05-03.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75471
Official notice
2024-05-03
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
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Brand: Covidien, Esoflip Dilation Catheter 30mm.
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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