Medtronic recall
Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
Why was Medtronic 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
N558983006
- Product
- Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 9 (1 still unused)
- Distribution
- Internationally to Japan.
- Recall date
- April 6, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)