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U.S. Department of Health and Human Services

Class 2 Device Recall Prometra Programmable Infusion Pump

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  Class 2 Device Recall Prometra Programmable Infusion Pump see related information
Date Initiated by Firm December 24, 2019
Date Posted February 10, 2020
Recall Status1 Open3, Classified
Recall Number Z-1120-2020
Recall Event ID 84653
PMA Number P080012 
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
Product Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082
Code Information All units with pump firmware version 0.26 manufactured from 2012 until the present time.  Serial Numbers 10JW4A32 10HW4A29 10JW4A44 10JW4A35 10HW4A45 10JW4A05 10JW4A08 10JW4A46 10JW4A36 10JW4A30 10JW4A39 10JW4A06 10JW4A21 10JW4A01 10JW4A27 10KW4A47 10JW4A29 10JW4A41 10KW4A122 10JW4A02 10KW4A05 10JW4A25 10KW4A38 10KW4A61 10KW4A11 10KW4A16 10KW4A27 10KW4A08 10KW4A117 10KW4A68 10KW4A99 10KW4A91 10KW4A20 10KW4A53 10KW4A106 10KW4A02 10JW4A20 10KW4A35 10KW4A18 10KW4A101 10AX4A21 10JW4A43 10KW4A73 10KW4A123 10KW4A67 10AX4B27 10KW4A31 10KW4A24 10AX4A37 10KW4A83 10AX4A36 10AX4A22 10AX4A10 10KW4A42 10KW4A119 10AX4B24 10KW4A89 10KW4A71 10KW4A116 10AX4A12 10DX4A79 10DX4A10 10AX4B06 10AX4B09 10DX4A95 10AX4A81 10AX4A98 10KW4A103 10AX4A96 10AX4A95 10AX4B82 10AX4A76 10KW4A48 10HY4C42 10KW4A09 10AX4A88 10DX4A32 10AX4A87 10AX4B92 10GX4B05 10GX4A30 10KW4A104 10AX4A14 10DX4A98 10GX4B21 10AX4A85 10KW4A85 10KW4A06 10AX4A73 10GX4A21 10GX4A09 10DX4A85 10GX4A82 10JW4A31 10GX4A87 10JW4A16 10GX4A85 10KW4A12 10GX4B16 10KW4A43 10GX4A34 10GX4A83 10AX4B78 10GX4B03 10GX4A38 10GX4B08 10KW4A29 10GX4B07 10KW4A30 10GX4A32 10AX4B90 10GX4A70 10AX4B81 10AX4B53 10GX4A92 10KY4A20 10KW4A52 10KW4A39 10GX4A19 10GX4A96 10DX4A21 10KX4A02 10DX4B07 10KX4A12 10KX4A15 10KW4A75 10GX4A99 10KX4A43 10GX4A45 10KX4A40 10KX4A41 10DX4A09 10DX4A74 10DX4A48 10KX4A42 10GX4A97 10GX4A10 10AX4B80 10KX4A59 10JW4A04 10KW4A44 10GX4A73 10KX4A14 10KX4A13 10GX4B15 10KX4A70 10KX4A57 10KX4A74 10KW4A25 10GX4A03 10GX4A63 10GX4A71 10KW4A108 10KX4A85 10KW4A105 10GX4A40 10GX4A14 10DX4A33 10BY4A40 10BY4A51 10BY4A39 10KX4A62 10BY4A25 10BY4A59 10BY4A36 10EY4A53 10KX4A10 10KX4A39 10EY4A27 10KX4A26 10EY4A26 10BY4A60 10EY4A38 10KX4A80 10BY4A57 10EY4A17 10EY4A83 10EY4A03 10BY4A48 10EY4A25 10EY4A29 10EY4A88 10EY4A99 10EY4A59 10EY4A05 10EY4A82 10EY4A19 10EY4A67 10EY4A89 10BY4A52 10KX4A17 10EY4A36 10EY4A58 10EY4A73 10EY4A43 10GX4A12 10KX4A78 10EY4A15 10BY4A34 10GY4A63 10EY4A37 10EY4A98 10KX4A25 10BY4A30 10GY4A16 10EY4A48 10KX4A76 10GY4A11 10GY4A19 10GY4A60 10GY4A55 10GY4A50 10GY4A49 10GY4A54 10BY4A31 10EY4A72 10KX4A11 10GY4A66 10GY4A40 10GY4A18 10EY4A94 10GY4A32 10EY4A13 10EY4A46 10GY4A72 10GY4A20 10GY4A06 10KX4A27 10KX4A08 10GY4A45 10KX4A30 10GY4A25 10KX4A32 10BY4A42 10GY4A15 10HY4B20 10GY4A35 10GY4A12 10GY4A58 10HY4B44 10GY4A23 10HY4B29 10GY4A21 10GY4A31 10GY4A53 10HY4B18 10KX4A29 10GY4A52 10HY4B16 10HY4B42 10HY4A97 10GY4A74 10HY4B48 10GY4A34 10HY4B41 10HY4B03 10EY4A76 10GY4A26 10HY4B23 10HY4B40 10HY4B25 10HY4B37 10HY4B55 10HY4B02 10HY4A85 10HY4B22 10HY4B54 10HY4B07 10HY4B80 10HY4B26 10HY4A78 10HY4C29 10HY4C11 10GY4A52¿ 10GX4B14 10KY4A41 10KX4A71 10GX4B02 10AX4B85 10HY4C03 10HY4B86 10HY4C16 10HY4C46 10HY4C34 10HY4B17 10HY4B65 10HY4B30 10HY4B62 10HY4B56 10HY4C35 10HY4B33 10HY4A81 10HY4C13 10HY4B10 10HY4C07 10HY4C27 10HY4C12 10HY4B96 10HY4B76 10HY4B24 10HY4C08 10HY4C39 10HY4C06 10HY4B83 10HY4C30 10HY4C36 10IY4A46 10HY4C40 10HY4B70 10IY4A29 10HY4C01 10HY4A98 10HY4B08 10IY4A17 10HY4C47 10HY4C32 10HY4C26 10IY4A38 10IY4A25 10HY4A80 10IY4A37 10IY4A43 10HY4C41 10IY4A51 10IY4A19 10IY4A33 10HY4B91 10HY4B51 10JY4A10 10KY4A60 10KY4A93 10KY4A15 10JY4A15 10KY4A21 10IY4A27 10IY4A13 10JY4A18 10JY4A07 10KY4A71 10KY4A39 10KY4A06 10HY4B97 10KY4A72 10KY4A86 10IY4A54 10KY4A87 10KY4A31 10AZ4A51 10KY4A25 10IY4A28 10KY4A50 10AZ4A35 10AZ4A24 10KY4A91 10AZ4A57 10IY4A31 10KY4A78 10KY4A84 10KY4A03 10KY4A82 10KY4A62 10KY4A44 10KY4A13 10HY4A79 10KY4A69 10AZ4A15 10JY4A28 10KY4A51 10JY4A16 10KY4A36 10AZ4A14 10AZ4A65 10KY4A94 10KY4A64 10KY4A47 10KY4A67 10JY4A03 10HY4A91 10AZ4A54 10HY4C23 10AZ4A08 10KY4A40 10AZ4A31 10BZ4A26 10KY4A79 10IY4A04 10EY4A60 10HY4B90 10KY4A90 10EY4A40 10KY4A30 10IY4A02 10AZ4A22 
Recalling Firm/
Manufacturer		 Flowonix Medical Inc
120 Forbes Blvd Ste 170
Mansfield MA 02048-1150
For Additional Information Contact Technical Solutions Department
855-356-9665
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = LKK and Original Applicant = Algorithm Sciences, Inc.
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