Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 14927 |
| Brand Name: | Medtronic Synchromed II Implantable Infusion Pump |
| Model: | |
| Affected: | All serial numbers |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Medtronic Inc |
| Brand Name: | SynchroMed EL Drug Infusion Pump |
| Model: | Models 8627-10, 8627L-10, 8627-18, 8627L-18 /CN |
| Affected: | All serial numbers |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Medtronic Inc |
| Issue: | Manufacturer is undertaking a Hazard Alert for the following 3 issues: Internal Electrical Shorting - an electrical short can occur when ions from the drug solution and humidity permeate through the drug patrhway tubing inside the pump and interact with the feedthough over time. This may present as a motor stall, or low battery reset/ alarm and leads to a loss or reduction in therapy. Priming Bolus - Patients may receive unintended drug at a high rate of infusion in the CSF during the priming bolus and a period of reduced concentration of drug wll occur following the priming bolus. Pump refill - This is a re-issue and update of information sent to patient in Dec 2010 |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 28/6/2013 |
