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Prometra II Programmable 20mL Pump. Catalog No. 93827 The… recallZ-1125-2020 · Flowonix Medical Inc · initiated Dec 24, 2019

Class II Open, Classified All recalls posted in February 2020

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Flowonix Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

FDA root cause category: Software change control

What the company is doing

***Updated 5/12/2023*** On May 11, 2023, the firm sent an URGENT MEDICAL DEVICE CORRECTION UPDATE letter to all affected customers, which informed them of an update to Flowonix's plan to correct the firmware issue. Flowonix will NOT be conducting an office-based pump firmware update for affected pumps implanted prior to January 2020. Healthcare providers were provided ongoing recommendations for Prometra and Prometra II pumps implanted prior to January 2020, which are impacted by this issue. Healthcare providers should contact their Flowonix Representative or our Technical Solutions Department (1-855-356-9665) in the event cessation of therapy or premature low battery is suspected and/or have general questions regarding this notice. *** On December 24, 2019, the firm notified affected users via an Urgent Medical Device Corrective Action Recall Notice. The firm advised customers of the product issue and reminded customers that the pumps are currently labeled only for use with Infumorph. Due to the low risk that this failure mode may occur, Flowonix is not recommending that pumps be explanted. Healthcare providers were recommended to inform patients regarding the symptoms and adverse health events associated with an unexpected pump stoppage and the appropriate steps to take in the event they suspect a stoppage. The firm will be implementing a correction of firmware errors to bring the pumps back into specification. The firm will follow up when the change has been completed. An office-based pump firmware update is being developed for patients currently implanted with the affected pumps. (Note, as of the 5/12/23 update, implanted pumps will not be receiving a firmware update.)

Recall details

Recall number
Z-1125-2020
Recall class
Class II
Status
Open, Classified
Initiated by the company
Dec 24, 2019
Posted by the FDA
Feb 10, 2020
Recalling firm
Flowonix Medical Inc
Quantity
1083 (OUS)
Product code
LKK
FDA submissions
P080012
Distribution
Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.

Product description

Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)

Code information (models, lots, serial numbers)

All units with pump firmware version 0.26 manufactured from 2012 until the present time.

Other devices under the same FDA submission

8 devices cleared under P080012 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 84653).

Sources and updates

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