FDA Device recall Z-1714-2019
Prometra Programmable Pump, Cat
- FDA Device
- Class II
- terminated
- Published 2019-06-12
On 2019-06-12 the FDA classified a Class II recall of Prometra Programmable Pump, Cat by Flowonix Medical, citing the pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a softwa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1714-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-21 |
| Published | 2019-06-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Flowonix Medical |
| Distribution | US |
Product
Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
Reason
The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped.
Identifiers
| code_info | Serial Numbers: 10AX4A03 10BY4A40 10EY4A35 10GX4A83 10HW4A31 10HY4C11 10JW4A28 10KW4A42 10KX4A48 10AX4A04 10…Serial Numbers: 10AX4A03 10BY4A40 10EY4A35 10GX4A83 10HW4A31 10HY4C11 10JW4A28 10KW4A42 10KX4A48 10AX4A04 10BY4A41 10EY4A36 10GX4A84 10HW4A45 10HY4C12 10JW4A29 10KW4A43 10KX4A49 10AX4A06 10BY4A42 10EY4A37 10GX4A85 10HW4A57 10HY4C13 10JW4A30 10KW4A44 10KX4A50 10AX4A10 10BY4A44 10EY4A38 10GX4A86 10HY4A77 10HY4C15 10JW4A31 10KW4A45 10KX4A52 10AX4A12 10BY4A45 10EY4A40 10GX4A87 10HY4A78 10HY4C16 10JW4A32 10KW4A46 10KX4A56 10AX4A14 10BY4A46 10EY4A41 10GX4A88 10HY4A79 10HY4C17 10JW4A33 10KW4A47 10KX4A57 10AX4A21 10BY4A47 10EY4A43 10GX4A89 10HY4A80 10HY4C18 10JW4A34 10KW4A48 10KX4A58 10AX4A22 10BY4A48 10EY4A44 10GX4A92 10HY4A81 10HY4C19 10JW4A35 10KW4A49 10KX4A59 10AX4A23 10BY4A49 10EY4A45 10GX4A94 10HY4A82 10HY4C20 10JW4A36 10KW4A50 10KX4A60 10AX4A28 10BY4A50 10EY4A46 10GX4A96 10HY4A83 10HY4C22 10JW4A37 10KW4A51 10KX4A62 10AX4A30 10BY4A51 10EY4A47 10GX4A97 10HY4A84 10HY4C23 10JW4A38 10KW4A52 10K |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1714-2019%22
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