Medtronic SynchroMed II Software Card Recall for Priming Bolus Function
Medtronic is recalling 22,298 SynchroMed II software application cards to update the priming bolus function and pump labeling.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class I, which is defined as a situation where use of the product is not likely to cause adverse health consequences. The issue is a software update and labeling correction.
Plain-English summary
Medtronic Neuromodulation is recalling 22,298 Model 8870 Software Application Cards for the SynchroMed II Implantable Drug Infusion System. The recall involves software cards with versions other than AAU01. The system includes the Model 8840 N'Vision Clinician Programmer and the Model 8637 SynchroMed II Implantable Drug Infusion Pump.
The recall is a follow-up to a May 2013 communication regarding the Priming Bolus function. Medtronic is updating the software application card to version AAU01 and the pump labeling to address this specific issue. The affected products were distributed worldwide, including in the United States, Germany, Greece, Australia, the United Kingdom, Switzerland, Italy, Norway, France, Canada, and Malta.
The SynchroMed II Programmable Pump is indicated for the chronic infusion of specific drugs or fluids, including morphine sulfate, ziconotide, baclofen, floxuridine, or methotrexate. Consumers and healthcare providers should contact Medtronic Neuromodulation for instructions on updating the software and labeling.
The recalled product
- 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.) Product
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 22,298
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- software application cards with versions other than AAU01
Distribution
Distributed nationwide across the United States.
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