Prometra Programmable Pump — Class II medical device recall Z-1714-2019
Terminated recall by Flowonix Medical Inc, reported 2019-06-12, distributed nationwide. The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered
| Recall number | Z-1714-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Flowonix Medical Inc, Mansfield, MA, United States |
| Recall initiated | 2019-03-21 |
| Classified | 2019-06-03 |
| Reported by FDA | 2019-06-12 |
| Terminated | 2020-06-05 |
| Distributed | Nationwide (US) |
| Quantity | 809 |
| Reason classes | software |
| Serial numbers | 10AX4A03, 10AX4A04, 10AX4A06, 10AX4A10, 10AX4A12, 10AX4A14, 10AX4A21, 10AX4A22, 10AX4A23, 10AX4A28, 10AX4A30, 10AX4A36, 10AX4A37, 10AX4A39, 10AX4A42, 10AX4A48, 10AX4A51, 10AX4A73, 10AX4A74, 10AX4A76, 10AX4A81, 10AX4A83, 10AX4A85, 10AX4A87, 10AX4A88 and 475 more |
| Model numbers | 11827 |
Product
Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1714-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.