Percutaneous Trial Lead Kit recall
Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal…
Why was Percutaneous Trial Lead Kit recalled?
The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals.
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?
Material 100077108, Batch 4519182
- Product
- Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal…
- Recalling firm
- St. Jude Medical, Inc.
- Quantity
- 4 units
- Distribution
- Distributed in the states of Texas and Illinois.
- Recall date
- October 8, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)