Z-1271-2016 Class II Terminated
FDA device recall Z-1271-2016 was initiated by Medtronic Neuromodulation on Feb 9, 2016 and is designated Class II. Reason for recall: Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intrathecal Catheter kit. We have identified that this kit may have been produced with incorrect outer… The recall status is terminated (terminated Aug 11, 2016). Affected quantity: 9 (1 still unused).
Recall Details
- Product Type
- Devices
- Report Date
- Apr 6, 2016
- Initiation Date
- Feb 9, 2016
- Termination Date
- Aug 11, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 (1 still unused)
Product Description
Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
Reason for Recall
Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intrathecal Catheter kit. We have identified that this kit may have been produced with incorrect outer package labels. As a result, it may not contain all components necessary to complete the implant procedure.
Distribution Pattern
Internationally to Japan.
Code Information
N558983006
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1271-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026