Recall Z-1121-2020 ยท LKK Pump, Infusion, Implanted, Programmable
Flowonix Medical Inc
Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
| Date | Feb 10, 2020 (initiated Dec 24, 2019) |
| Status | Open, Classified |
| Reason | A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system. |
| Root cause | Software change control |
| Action | ***Updated 5/12/2023*** On May 11, 2023, the firm sent an URGENT MEDICAL DEVICE CORRECTION UPDATE letter to all affected customers, which informed them of an update to Flowonix's plan to correct the firmware issue. Flowonix will NOT be conducting an office-based pump firmware update for affected pumps implanted prior to January 2020. Healthcare providers were provided ongoing recommendations for Prometra and Prometra II pumps implanted prior to January 2020, which are impacted by this issue. Healthcare providers should contact their Flowonix Representative or our Technical Solutions Departm |
| Quantity | 6670 (US) |
| Distribution | Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.