St. Jude Medical Percutaneous Trial Lead Kit Manual Recall
St. Jude Medical is recalling four units of the Percutaneous Trial Lead Kit Model 3086 because the included manual contained information for devices not approved in the US.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving a documentation error (incorrect manual) rather than a direct physical hazard to the device itself, fitting the criteria for minor labeling or documentation issues.
Plain-English summary
St. Jude Medical, Inc. is recalling four units of the Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). This product is used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation. The specific units affected are identified by Material 100077108 and Batch 4519182.
The recall was initiated because the Directions for Use (DFU) manual included with these kits contained information for devices that are not approved in the United States. The correct US-approved versions of the manuals were sent to customers to replace the incorrect international manuals.
The affected units were distributed in the states of Texas and Illinois. Customers who received these kits should use the correct US-approved manuals provided by the manufacturer.
The recalled product
- Product
- Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
- Manufacturer
- St. Jude Medical, Inc.
- Hazard
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Material 100077108
- Batch 4519182
Distribution
Part of a larger recall action
This product is one of 2 recalled by St. Jude Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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