Medtronic SynchroMed II recall
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Product…
Why was Medtronic SynchroMed II recalled?
Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the SynchroMed implantable infusion pump. The unintended delivery of drug can contribute to patient overdose or underdose symptoms which may be clinically relevant.
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?
all SynchroMed II pumps
- Product
- Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Product…
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 261,109 total devices estimated implanted Worldwide
- Distribution
- Worldwide Distribution - USA Nationwide
- Recall date
- July 3, 2013
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)