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.
What this means for you
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.
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