FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: 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
- Recall number
- Z-1912-2008
- 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,
- Status
- Terminated
- Initiated
- 2008-03-01
- Posted
- 2008-09-16
- Terminated
- 2012-06-05
- Reason
- Medtronic Model 3777-75 Octad 1x8 Leads, Lot V030733 contain accessory stylets that are not the correct length.
- 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
- 3
- Distribution
- NC, FL
- Lot, serial or model codes
- Model 3777-75, Lot number V030733, Serial numbers V030733017, V030733018, V030733026.
- 510(k) numbers
- not on file
- PMA numbers
- ["P840001S075"]
- Product code
- LGW
- Firm FEI
- 2182207
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28