Mar

2017

Medtronic SynchroMed Infusion System Class I

Company:Medtronic Neuromodulation
Date of Enforcement Report 3/8/2017
Class l

PRODUCT

Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N’Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.)
Recall Number Z-0788-2017

REASON
Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. Medtronic is updating the Model 8870 software application card (to version AAU01) and the Synchro

RECALLING FIRM/MANUFACTURER
Medtronic Neuromodulation, Minneapolis, MN on 10/3/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
22,298 software cards

DISTRIBUTION
Nationwide and Internationally

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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 SynchroMed Infusion System Class I

Amy Sellers

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