Medtronic SynchroMed EL Programmable pumps recall
Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.)…
Why was Medtronic SynchroMed EL Programmable pumps 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 EL pumps
- Product
- Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.)…
- 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)