Medtronic SynchroMed II Implantable Drug Infusion recall: Software Issue
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician…
Why was Medtronic SynchroMed II Implantable Drug Infusion recalled?
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 SynchroMed pump labeling to address the priming bolus issue.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
software application cards with versions other than AAU01
- Product
- Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician…
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 22,298 software cards
- Distribution
- Worldwide Distribution - (US Nationwide) Internationally to Germany, Greece, Australia, United Kingdom, Switzerland, Italy, Norway, France, Canada, and Malta.
- Recall date
- March 8, 2017
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)