Z-1122-2020Class II

Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242

Name: Z-1122-2020 Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
Creator: Flowonix Medical Inc
Published: 2019-12-24
License: https://open.fda.gov/license/

Flowonix Medical Inc / initiated 2019-12-24 / Open, Classified / root cause: software

FDA source

Flowonix Medical Inc began a recall of Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242 on 2019-12-24. FDA classified it as Class II and gives the reason as "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"...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1122-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-12-24
Posted: 2020-02-10
Recalling firm: Flowonix Medical Inc
Product: Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software change control
Action: ***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.)
Quantity in commerce: 6670 (US)
Distribution: Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.
Product codes and lots: All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers 10GC4A24X 10GC4A02X 10GC4A18X 10GC4A22X 10GC4A14X 4MA00044X 4MA00006X 10GC4A12X 10GC4A09X 10GC4A06X 10GC4A21X 4MA00008X 10GC4A01X 10GC4A20X 10GC4A11X 10GC4A16X 10GC4A17X 4MA00045X 4MA00055X 10GC4A08X 4MA00032X 4MA00031X 4MA00010X 4MA00042X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1122-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1120-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-10
Z-1121-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-10
Z-1122-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-10
Z-1123-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-10
Z-1124-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-10
Z-1125-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-10

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)