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Medtronic's EnTrust Dual Chamber (2018-06-21) — recall 61101

Health Canada — Medical Devices · Canada · 2018-07-05 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
61101
Date of alert
2018-07-05
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: There is a potential for loss of high voltage and anti-tachycardia pacing therapy in entrust Implantable Cardioverter Defibrillators (ICDS) as they near Elective Replacement Indicator (ERI) voltage. Under certain circumstances, the device may display an immediate End Of Life (EOL) observation with no prior ERI alert. Though no ERI alert is triggered there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL observation, leading to a loss of high voltage and anti-tachycardia pacing therapy. Bradycardia therapies will continue to operate as expected.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/medtronic-s-entrust-dual-chamb

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