Medtronic MiniMed Class III

Company: Medtronic MiniMed
Date of Enforcement Report: 1/21/04
Class: III

PRODUCT
Medtronic MiniMed. Model 7311 Solutions Pumps
and Meters Software. Recall # Z-0265-04.

REASON
Accessory software fails to report certain reports following download of data from 712 pump.

CODE
Version 5.0A.

RECALLING FIRM/MANUFACTURER
Medtronic MiniMed, Northridge, CA, by visit or FedEx software on CD-rom beginning on November 19, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,020.

DISTRIBUTION
Nationwide and Internationally.

About the author

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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