St. Jude Medical Percutaneous Trial Lead Kit Manual Recall
St. Jude Medical is recalling 2 units of Percutaneous Trial Lead Kit Model 3046 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation error (incorrect manual) with no reported injuries or illnesses, fitting the rubric criteria for documentation issues.
Plain-English summary
St. Jude Medical, Inc. is recalling 2 units of the Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). This device is used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation. The specific units affected are identified by Material 100077113 and Batch 4558337.
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 have already been 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 verify that they have the correct US-approved manual. If they have not yet received the replacement, they should contact St. Jude Medical for assistance.
The recalled product
- Product
- Percutaneous Trial Lead Kit Model 3046 (4 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
- 2
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 100077113
- Batch 4558337
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 →- SevereSt 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 47 Ellipse VR Implantable 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
Same hazard · documentation error
See all →- LowMindray cPM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- LowMindray Recalls Passport Series Patient Monitor Operator's Manuals
FDA (Devices) · 2026-10-14
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
Similar recalls
- HighSt. Jude Medical DBS Leads Recalled for Incorrect Electrode Material
FDA (Devices) · 2018-12-19
- ModerateMedtronic Spinal Cord Stimulation Leads Recalled for Labeling Deficiencies
FDA (Devices) · 2016-03-02
- ModerateMedtronic Vectris Trial Screening Lead Kit Recalled for Needle Defect
FDA (Devices) · 2018-07-25
- LowBoston Scientific Recalls Spinal Cord Stimulation Leads Due to Labeling Error
FDA (Devices) · 2020-06-03
- LowSt. Jude Medical Recalls Fast-Cath Transseptal Guiding Introducers Due to Packaging Error
FDA (Devices) · 2013-01-09
- HighNuvectra Recalls Algovita Spinal Cord Stimulation Leads Due to Stylet Protrusion
FDA (Devices) · 2016-12-28