US Clinical 20mL Programmable Pump. Catalog No. 01827 The… recallZ-1123-2020 · Flowonix Medical Inc · initiated Dec 24, 2019
Class II Open, Classified All recalls posted in February 2020
Is my device affected?
- 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.
- 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.
- 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-1123-2020
- 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
- 6670 (US)
- 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
US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082
Code information (models, lots, serial numbers)
All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers 10HW4A57 10AX4A06 36ES4A15 36AR4A04 36AR4A06 36AR4A13 36HS4A10 36HS4A54 36JN4A04 36JN4A06 36JN4A07 36JN4A09 36JN4A13 36JN4A14 36JN4A15 36JN4A18 36JN4A23 36JN4A28 36JN4A35 36KN4A11 36KN4A16 36KN4A23 36KN4A27 36KN4A33 36KN4A34 36KN4A41 36HS4A01 10IT4A21 36HS4A14 36HS4A26 36BS4A17 36ES4A28 36ES4A33 36ES4A08 10IT4A16 36FR4A13 36HS4A61 10ET4A07 36HS4A46 10ET4A20 36HS4A25 36HS4A43 10ET4A02
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.
- Prometra II Pump 13827Flowonix Medical, Inc. · Pump, Infusion, Implanted, Programmable40 deaths859 reports
- Prometra Intrathecal Catheter 11823Flowonix Medical, Inc. · Pump, Infusion, Implanted, Programmable1 death322 reports
- Prometra Programmable Pump 11827Flowonix Medical, Inc. · Pump, Infusion, Implanted, Programmable9 deaths83 reports
- Prometra Patient Therapy Controller 12860Flowonix Medical, Inc. · Pump, Infusion, Implanted, Programmable58 reports
- Prometra Catheter Revision Kit 11830Flowonix Medical, Inc. · Pump, Infusion, Implanted, Programmable42 reports
- Prometra Programmable Pump 16827Flowonix Medical, Inc. · Pump, Infusion, Implanted, Programmable32 reports
- Prometra Programmer 12828Flowonix Medical, Inc. · Pump, Infusion, Implanted, Programmable10 reports
- Prometra Refill Kit 11825Flowonix Medical, Inc. · Pump, Infusion, Implanted, Programmable1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 84653).
- Z-1120-2020 · Open, ClassifiedPrometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082
- Z-1121-2020 · Open, ClassifiedPrometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
- Z-1122-2020 · Open, ClassifiedPrometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
- Z-1124-2020 · Open, ClassifiedPrometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)
- Z-1125-2020 · Open, ClassifiedPrometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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