Prometra Programmable Pump
Medical device recall Z-1714-2019. Published in FDA’s Enforcement Report on Jun 12, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 12, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 809 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
809, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,996 characters
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 10KX4A63 10AX4A36 10BY4A52 10EY4A48 10GX4A98 10HY4A85 10HY4C26 10JW4A39 10KW4A53 10KX4A64 10AX4A37 10BY4A53 10EY4A51 10GX4A99 10HY4A87 10HY4C27 10JW4A40 10KW4A54 10KX4A65 10AX4A39 10BY4A54 10EY4A52 10GX4B02 10HY4A90 10HY4C28 10JW4A41 10KW4A55 10KX4A66 10AX4A42 10BY4A55 10EY4A53 10GX4B03 10HY4A91 10HY4C29 10JW4A42 10KW4A56 10KX4A67 10AX4A48 10BY4A56 10EY4A54 10GX4B04 10HY4A92 10HY4C30 10JW4A43 10KW4A57 10KX4A68 10AX4A51 10BY4A57 10EY4A55 10GX4B05 10HY4A95 10HY4C32 10JW4A44 10KW4A58 10KX4A69 10AX4A73 10BY4A58 10EY4A56 10GX4B06 10HY4A97 10HY4C34 10JW4A45 10KW4A59 10KX4A70 10AX4A74 10BY4A59 10EY4A58 10GX4B07 10HY4A98 10HY4C35 10JW4A46 10KW4A60 10KX4A71 10AX4A76 10BY4A60 10EY4A59 10GX4B08 10HY4B01 10HY4C36 10JW4A47 10KW4A61 10KX4A72 10AX4A81 10BZ4A24 10EY4A60 10GX4B09 10HY4B02 10HY4C37 10JW4A48 10KW4A63 10KX4A73 10AX4A83 10BZ4A26 10EY4A61 10GX4B10 10HY4B03 10HY4C39 10JY4A01 10KW4A64 10KX4A74 10AX4A85 10BZ4A32 10EY4A62 10GX4B11 10HY4B05 10HY4C40 10JY4A03 10KW4A65 10KX4A76 10AX4A87 10BZ4A46 10EY4A63 10GX4B12 10HY4B07 10HY4C41 10JY4A06 10KW4A66 10KX4A77 10AX4A88 10BZ4A70 10EY4A64 10GX4B13…
FDA’s list runs to 7,125 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 21, 2019.
- FDA classified it on Jun 3, 2019.
- FDA’s Enforcement Report published it on Jun 12, 2019.
- FDA terminated it on Jun 5, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Flowonix Medical Inc, of Mansfield, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 7,125 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.