Recalls / —
—#210208
Product
SynchroMed II Infusion Pump. Product Number: 8637-20
- FDA product code
- LKK — Pump, Infusion, Implanted, Programmable
- Device class
- Class 3
- Medical specialty
- Unknown
- Affected lot / code info
- GTIN Number: 00643169630505. Serial Number: NGP004814H
Why it was recalled
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
Root cause (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- Medtronic Neuromodulation
- Address
- 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568
Distribution
- Distribution pattern
- US Nationwide distribution in the state of Mississippi.
Timeline
- Recall initiated
- 2024-09-11
- Posted by FDA
- 2024-10-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #210208. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.