Z-1723-2014 Class II Terminated
FDA device recall Z-1723-2014 was initiated by Medtronic Neuromodulation on May 2, 2014 and is designated Class II. Reason for recall: Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits. The recall status is terminated (terminated Oct 7, 2014). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 11, 2014
- Initiation Date
- May 2, 2014
- Termination Date
- Oct 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
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.
Distribution Pattern
Distributed in the state of CT.
Code Information
N457062003
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1723-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026