Z-1912-2008

Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Contents of the inner...

Name: Z-1912-2008 Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Contents of the inner...
Creator: Medtronic Neuromodulation
Published: 2008-03-01
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2008-03-01 / Terminated

FDA source

Medtronic Neuromodulation began a recall of Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Contents of the inner package are STERILE. Method of sterilization: Ethylene... on 2008-03-01. The reason FDA records is "Medtronic Model 3777-75 Octad 1x8 Leads, Lot V030733 contain accessory stylets that are not the correct length". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1912-2008
Status: Terminated
Initiated: 2008-03-01
Posted: 2008-09-16
Terminated: 2012-06-05
Recalling firm: Medtronic Neuromodulation
Product: Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide, Rx Only,
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: Medtronic Model 3777-75 Octad 1x8 Leads, Lot V030733 contain accessory stylets that are not the correct length.
FDA root cause: Mixed-up of materials/components
Action: Consignees were sent a Medtronic Letter dated March 2008. The letter described the product model / serial number and problem. It gave the option in assisting in returning the product for replacement or credit. A Medtronic Inter-Office Memo was also issued to "Affected Field Personnel" . The memo described the product /problem and the action required . Contact Medtronic Neuromodulation Quality at 651-367-0628 if you have questions.
Quantity in commerce: 3
Distribution: NC, FL
Product codes and lots: Model 3777-75, Lot number V030733, Serial numbers V030733017, V030733018, V030733026.

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)