Z-2322-2008

Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery operated...

Name: Z-2322-2008 Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery operated...
Creator: Medtronic Neuromodulation
Published: 2008-05-12
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2008-05-12 / Terminated / root cause: manufacturing process

FDA source

Medtronic Neuromodulation began a recall of Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to... on 2008-05-12. The reason FDA records is "Medtronic is retrieving four (4) patient programmers that were not properly loaded with application software. The application software is needed for a patient programmer to synchronize and bond with a neurostimulation...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2322-2008
Status: Terminated
Initiated: 2008-05-12
Posted: 2008-09-20
Terminated: 2008-11-21
Recalling firm: Medtronic Neuromodulation
Product: Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to control and monitor external and implantable devices. The minimum amount of control involves the ability to turn therapy ON or OFF; maximal control allows the patient to select from different therapies and adjust the parameters with in the set therapy limits.
Product code: EZW Stimulator, Electrical, Implantable, For Incontinence
Reason for recall: Medtronic is retrieving four (4) patient programmers that were not properly loaded with application software. The application software is needed for a patient programmer to synchronize and bond with a neurostimulation device. Without this functionality a patient programmer is not useable and can not communicate with a neurostimulation device.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A letter was sent to each account telling them of the issue and to let them know that Medtronic is retrieving the affected devices. Medtronic Reps were to visit affected accounts to notify them of the recall, locate the affected device and return it. Rep is to complete the reply card and fax to Medtronic Neuromodulation. If you have questions, contact your Medtronic representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.
Quantity in commerce: 2
Distribution: GA, MO, NC, TX no OUS distribution
Product codes and lots: serial numbers: NJD058707N, NJD062024N, NJD063259N, and NJD063324N

Product code EZW

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)