FDAFDA · Food and drugs·Recall number Z-1723-2014
Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 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 Model 8780 Ascenda Intrathecal Catheter.
Published June 11, 2014 · Recall initiated: May 2, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Neuromodulation
- Distributor
- Distributed in the state of CT.
- Lot
- N457062003
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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