Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
Reported: April 6, 2016 Initiated: February 9, 2016 #Z-1271-2016
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.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 9 (1 still unused)
- Distribution
- Internationally to Japan.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.. Recalled by Medtronic Neuromodulation. Units affected: 9 (1 still unused).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 6, 2016. Severity: Moderate. Recall number: Z-1271-2016.
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