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U.S. Department of Health and Human Services

Safety

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Medtronic 8870 Software Application Card Version AAA 02

Audience: Healthcare professionals and risk managers

FDA and Medtronic notified healthcare professionals of a Class I recall of all Medtronic Model 8870 software application cards, Version AAA 02, used in conjunction with the Model 8840 N'Vision Clinician Programmer. This software application card is used to control the administration of medication of Synchromed and Synchromed EL implantable infusion pumps. Several pump infusion modes require the entry of a time duration or interval. Medtronic has received reports of the entry of hours into the minutes field, which has resulted in deaths and injuries due to drug overdose.

[September 23, 2004 - Recall Notice - FDA]