Reported Jul 3, 2013 · Terminated
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized…
Medtronic Neuromodulation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave NE · Minneapolis, MN · 55432-3568
Is this the product you have?
- Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II infusion system include the pump, catheter,r and catheter accessories The SynchroMed II Programmable Pump is indicated when patient therapy requires
- the chronic infusion of drugs or fluids—
- Lot codes and dates
- all SynchroMed II pumps
- Amount recalled
- 261,109 total devices estimated implanted Worldwide
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Why it was recalled
Stop using this product now
Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and lead to a loss of or reduction in therapy which may result in the return of und
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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