Reported Jun 11, 2014 · Terminated
Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is…
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
3 of 3 products
| Model / number | Product as published |
|---|---|
8780 | Ascenda Intrathecal Catheter. The implantable Medtronic |
8780 | Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a |
8780 | Ascenda Intrathecal Catheter. |
- Lot codes and dates
- N457062003
- Amount recalled
- 1
Where it was sold
Why it was recalled
Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
This product could cause temporary or reversible health problems — stop using it.
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