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.
Reported: June 11, 2014 Initiated: May 2, 2014 #Z-1723-2014
Product Description
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.
Reason for Recall
Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 1
- Distribution
- Distributed in the state of CT.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Neuromodulation. Units affected: 1.
Why was this product recalled? ▼
Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 11, 2014. Severity: Moderate. Recall number: Z-1723-2014.
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