Sep

2004

Medtronic Inc Class I

Company: Medtronic Inc
Date of Enforcement Report: 9/29/04
Class: I

PRODUCT
8870 software application card Version AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N’Vision Clinician Program. Recall # Z-1334-04.

REASON
Users may mistakenly enter a periodic bolus interval into the minutes field, rather than the hours field, resulting in drug overdoses. This issue is limited to programming the SynchroMed and SynchroMed EL pumps.

CODE
Software Version AAA 02, BBB 04, BBC 02, and BBD 01.

RECALLING FIRM/MANUFACTURER
Medtronic Inc, Neurological & Spinal Division, Columbia Heights, MN, by letters on August 24, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4,466 cards.

DISTRIBUTION
Nationwide and Internationally.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Medtronic Inc Class I

Amy Sellers

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