FDA Recall
Open, Classified
SynchroMed II Infusion Pump. Product Number: 8637-20
Recall: Z-0137-2025
·
Initiated September 11, 2024
Recall
- Recall Number
- Z-0137-2025
- Event Number
- 95419
- Firm
- Medtronic Neuromodulation
- FEI Number
- 2182207
- Product Code
- LKK
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- September 11, 2024
- Posted
- October 21, 2024
- Address
- 7000 Central Ave Ne, Minneapolis, MN, 55432-3568
Description
SynchroMed II Infusion Pump. Product Number: 8637-20
Reason
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
Action
On 11-September-2024, a Medtronic representative was sent to the physician s facility where the representative provided the communication and confirmation form to the physician. The physician was asked to sign the confirmation form indicating they read the notification. The representative reset the patient s pump.
Distribution
US Nationwide distribution in the state of Mississippi.
Quantity
1 unit