SynchroMed II implantable drug infusion pump recall
SynchroMed II implantable drug infusion pump, Model 8637-40,
Why was SynchroMed II implantable drug infusion pump recalled?
Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error code prevented the physician from updating the pump; however the pump was providing therapy.
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?
Serial Number NGV526743H
- Product
- SynchroMed II implantable drug infusion pump, Model 8637-40,
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 1
- Distribution
- IL
- Recall date
- April 5, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)