Medtronic Neurological Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis, MN 55432-5604. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis, MN 55432-5604.
Brand
Medtronic Neurological
Lot Codes / Batch Numbers
Model 3777, Lot V009545
Products Sold
Model 3777, Lot V009545
Medtronic Neurological is recalling Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufacture due to Model 3777 Standard Octad Lead (Lot V009545) and Model 3778 Compact Octad Lead (Lot V009546) were mispackaged. The result of this error is that lead . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Model 3777 Standard Octad Lead (Lot V009545) and Model 3778 Compact Octad Lead (Lot V009546) were mispackaged. The result of this error is that lead kits labeled 3777 lot V009545 may contain a 3778 compact-spaced lead, while those labeled 3778 lot V009546 may contain a 3777 standard-spaced lead. The result of this error is an overall increase or decrease of 14 mm in the electrode coverage.
Recommended Action
Per FDA guidance
Medtronic representatives retrieved non-implanted devices. An Urgent Medical Device Recall letter was sent to physicians to describe the issue and patient management information.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026