Z-1713-2019Class II

Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra...

Name: Z-1713-2019 Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra...
Creator: Flowonix Medical Inc
Published: 2019-03-21
License: https://open.fda.gov/license/

Flowonix Medical Inc / initiated 2019-03-21 / Terminated / root cause: software

FDA source

Flowonix Medical Inc began a recall of Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion on 2019-03-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1713-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-21
Posted: 2019-06-03
Terminated: 2020-06-05
Recalling firm: Flowonix Medical Inc
Product: Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
Product code: LKK Pump, Infusion, Implanted, Programmable
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.
Root cause tag: software
FDA root cause: Software change control
Action: On March 21, 2019, the firm issued Urgent Recall Notices to customers to inform them of the product issue. In May 2019, the firm sent updated communications to customers: Healthcare providers who have Clinician Programmers with SW 2.00.29 were sent a follow-up recall letter. This letter included the information that the pump stop following "Error Code 115" will only occur after the Bridge or Demand Bolus is complete, which could take up to seventy-two (72 hours). In addition, in the event of any cause of an "Error Code 115", the pump sounds a one-beep alarm and then shuts down. This behavior differs from the Instructions for Use, which state that the pump will sound three long (half second) beeps every 30 minutes for all critical errors. As it is unlikely that the patient will notice the single beep, there may be a significant delay in the patient becoming aware that the pump has stopped delivering therapy which may in turn delay resumption of drug therapy. Healthcare providers who have Clinician Programmers with any other version of the software and the implant pumps received a Corrective Action Notice. This notice included the information from the preceding paragraph, noting the discrepant alarm behavior for "Error Code 115" could be missed by the patient. Customers with the new Prometra Clinician Programmer software (v. 2.00.29) were asked to do the following: 1. STOP using the Periodic Flow or Multiple Rates flow mode functions in combination with a Bridge or Demand Bolus using the Clinician Programmer with Software Version 2.00.29. The error only occurs when these functions are used together. a. In the event that a Bridge or Demand Bolus is needed, convert the patient to Constant Flow Mode, then program the Bridge or Demand Bolus as needed (instructions for use PL-11803-04, page 30). Once the bolus is complete, revisit the patient or have him/her return to your clinic for programming back into their original flow mode. 2. IDENTIFY
Quantity in commerce: 40
Distribution: US nationwide distribution.
Product codes and lots: Software v.2.00.29 Serial numbers: D18L0003 D18L0022 D18L0013 D18L0035 D18L0004 D18L0025 D18L0014 D18L0036 D18L0006 D18L0026 D18L0015 D18L0037 D18L0010 D18L0027 D18L0016 D18L0038 D18L0009 D18L0028 D18L0017 D18L0034 D18L0008 D18L0029 D18L0018 D18L0039 D18L0007 D18L0030 D18L0019 D18L0040 D18L0011 D18L0031 D18L0021 D18L0041 D18L0005 D18L0032 D18L0023 D18L0042 D18L0012 D18L0033 D18L0024 D18L0020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1713-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1712-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-03
Z-1713-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-03
Z-1714-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-03
Z-1715-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-03
Z-1716-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-03

Product code LKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)