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.
What this means for you
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.
See all 2 products in this recall →Related recalls
Same manufacturer · St. Jude Medical, Inc.
See all →- HighSt Jude Medical Recalls 15 Ellipse DR Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
- SevereSt Jude Medical Recalls 42 Ellipse DR Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
- SevereSt Jude Medical Recalls 27 Ellipse VR Implantable Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
- SevereSt Jude Medical Recalls 21 Ellipse DR Implantable Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
- SevereSt Jude Medical Recalls Ellipse VR Cardioverter Defibrillators Due to Electrical Failures
FDA (Devices) · 2019-08-14
Same hazard · documentation error
See all →- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModeratePower Over Fiber Base Modules Recalled Due to Incorrect Laser Classification and Labeling
FDA (Devices) · 2026-08-05
- ModerateEmbrace standard drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01
- ModerateEmbrace shoulder drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01