Home › Device types › LKK
Pump, Infusion, Implanted, Programmable
FDA product code LKK · Class 3 · Unknown
194
Registered devices
116,752
Adverse events
132
Recalls
0
510(k) clearances
Devices with this code
NA — Medos International SàrlNA — MEDTRONIC, INC.SYNCHROMED™ III — MEDTRONIC, INC.N/A — MEDTRONIC, INC.NA — MEDTRONIC, INC.MEDSTREAM — Cerenovus, Inc.N'VISION® — MEDTRONIC, INC.NA — MEDTRONIC, INC.N'Vision — MEDTRONIC, INC.N/A — MEDTRONIC, INC.MEDSTREAM — Medos International SàrlNA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.N/A — MEDTRONIC, INC.NA — MEDTRONIC, INC.INDURA® — MEDTRONIC, INC.ISOMED® — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-11 | Boston Scientific Corporation | There is the potential for leakage along the drug pathway from the pump through the end of the catheter. |
| 2026-04-08 | Medtronic Neuromodulation | Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecu |
| 2025-01-09 | Medtronic Neuromodulation | Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump. |
| 2024-11-21 | Medtronic Neuromodulation | Software issues were identified in application version 2.x. |
| 2024-11-21 | Medtronic Neuromodulation | Software issues were identified in application version 2.x. |
| 2024-11-21 | Medtronic Neuromodulation | Software issues were identified in application version 2.x. |
| 2024-11-21 | Medtronic Neuromodulation | Software issues were identified in application version 2.x. |
| 2024-09-11 | Medtronic Neuromodulation | Potential for error and inability to interrogate pump due to data corruption in the pump memory. |
| 2024-05-10 | Medtronic Neuromodulation | Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth int |
| 2023-11-13 | Medtronic Neuromodulation | Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the |
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