FDA Devices recall · Reported June 12, 2019
Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
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 softw…
Flowonix Medical Inc recalled Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion. - a moderate-severity action.
Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion. was recalled by Flowonix Medical Inc in June 12, 2019. Reason: The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggere…. Check the official notice for the remedy. Verify recall #Z-1714-2019 with the FDA Devices before acting.
The recall
Flowonix Medical Inc issued this moderate-severity FDA Devices recall-The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggere….
- Moderate
- severity level
- 809 units
- affected scope
- Class II
- classification
- June 12, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1714-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1714-2019 |
| Date reported | June 12, 2019 |
| Date initiated | March 21, 2019 |
| Recalling firm | Flowonix Medical Inc |
| Firm location | Mansfield, MA |
| Affected scope | 809 |
| Distribution | US nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1714-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
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Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
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Methodology · Corrections · Archive as of August 2026