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Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for… recallZ-1536-06 · Medtronic Neurological · initiated Aug 2, 2006

Terminated All recalls posted in September 2006

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Neurological or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Other

What the company is doing

Medtronic representatives retrieved non-implanted devices. An Urgent Medical Device Recall letter was sent to physicians to describe the issue and patient management information.

Recall details

Recall number
Z-1536-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 2, 2006
Posted by the FDA
Sep 29, 2006
Recalling firm
Medtronic Neurological
Quantity
22 total
Product code
LGW
FDA submissions
P840001
Distribution
Nationwide distribution --- including states of CA, GA, KY, LA, and TX.

Product description

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.

Code information (models, lots, serial numbers)

Model 3777, Lot V009545

Other devices under the same FDA submission

116 devices cleared under P840001 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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