Z-1694-2017 Class II Terminated
FDA device recall Z-1694-2017 was initiated by Medtronic Neuromodulation on Feb 9, 2017 and is designated Class II. Reason for recall: Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error code prevented the… The recall status is terminated (terminated Sep 4, 2018). Affected quantity: 1.
Recall details
- Product Type
- Devices
- Report Date
- Apr 5, 2017
- Initiation Date
- Feb 9, 2017
- Termination Date
- Sep 4, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product description
SynchroMed II implantable drug infusion pump, Model 8637-40,
Reason for recall
Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error code prevented the physician from updating the pump; however the pump was providing therapy.
Distribution pattern
IL
Code information
Serial Number NGV526743H
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1694-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026