Class 2 Device Recall Prometra Programmable Infusion Pump

• Date Initiated by Firm: December 24, 2019
• Date Posted: February 10, 2020
• Recall Status: Open, Classified
• Recall Number: Z-1121-2020
• Recall Event ID: 84653
• PMA Number: P080012
• Product Classification: Pump, infusion, implanted, programmable - Product Code LKK
• Product: Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
• Code Information: All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers 10HW4A31 10AZ4A69X 10AZ4A07X 10BZ4A16X 10BZ4A61X 10BZ4A41X 10AZ4A48X 10AZ4A50X 10AZ4A23X 10AZ4A36X 10AZ4A42X 10BZ4A37X 10BZ4A64X 10BZ4A12X 10CZ4B09X 10CZ4A95X 10CZ4B22X 10BZ4A18X 10CZ4A79X 10CZ4A86X 10CZ4A96X 10CZ4A88X 10CZ4A80X 10CZ4A85X 10CZ4A81X 10CZ4A82X 10CZ4A78X 10CZ4A91X 10CZ4A94X 10CZ4A90X 10CZ4A77X 10CZ4B28X 10CZ4B05X 10CZ4B15X 10CZ4B21X 10CZ4A87X 10CZ4B32X 10AZ4A41X 10CZ4B23X 10CZ4A93X 10CZ4B01X 10CZ4B17X 10CZ4B04X 10CZ4B30X 10BZ4A55X 10CZ4B08X 10CZ4A76X 10CZ4B33X 10CZ4B20X 10DZ4A01X 10DZ4A58X 10DZ4A19X 10CZ4B36X 10CZ4A84X 10DZ4A18X 10CZ4B24X 10DZ4A76X 10BZ4A30X 10CZ4B26X 10BZ4A09X 10DZ4A51X 10DZ4A93X 10DZ4A32X 10CZ4B03X 10DZ4A89X 10BZ4A11X 10DZ4A30X 10CZ4B25X 10DZ4A65X 10DZ4A05X 10DZ4A98X 10DZ4A08X 10DZ4A42X 10DZ4A77X 10CZ4A92X 10DZ4A35X 10DZ4A80X 10DZ4A92X 10DZ4A88X 10DZ4A07X 10BZ4A39X 10DZ4A73X 10DZ4A53X 10DZ4A28X 10DZ4A84X 10DZ4A45X 10CZ4B14X 10DZ4A40X 10DZ4A72X 10DZ4A64X 10DZ4A79X 10DZ4A60X 10DZ4A82X 10DZ4A37X 10DZ4B39X 10DZ4A54X 10DZ4A67X 10CZ4B29X 10BZ4A59X 10DZ4A20X 10DZ4A38X 10DZ4B04X 10DZ4A36X 10DZ4A91X 10DZ4B37X 10DZ4B06X 10DZ4A34X 10DZ4A25X 10DZ4B24X 10DZ4B49X 10DZ4B38X 10CZ4A89X 10DZ4B05X 10DZ4A15X 10DZ4A43X 10DZ4B54X 10BZ4A25X 10DZ4A66X 10DZ4B53X 10DZ4A29X 10DZ4A23X 10DZ4B08X 10DZ4A21X 10DZ4B40X 10DZ4A83X 10DZ4A17X 10DZ4A62X 10DZ4B19X 10DZ4B46X 10EZ4A36X 10DZ4B16X 10DZ4A87X 10DZ4B25X 10DZ4B43X 10DZ4B10X 10DZ4B61X 10DZ4B50X 10DZ4B07X 10DZ4B48X 10DZ4B26X 10DZ4B29X 10DZ4A27X 10CZ4B27X 10EZ4A02X 10DZ4B22X 10DZ4B15X 10EZ4A46X 10EZ4A27X 10EZ4A01X 10DZ4A47X 10DZ4A81X 10DZ4A33X 10EZ4A30X 10EZ4A26X 10EZ4A51X 10DZ4B03X 10EZ4A37X 10EZ4A13X 10EZ4A39X 10EZ4A35X 10DZ4B45X 10EZ4A28X 10DZ4A10X 10FZ4A34X 10CZ4B35X 10EZ4A09X 10EZ4A43X 10EZ4A05X 10EZ4A17X 10EZ4A16X 10DZ4B21X 10DZ4A94X 10EZ4A19X 10EZ4A45X 10DZ4A44X 10DZ4A68X 10EZ4A25X 10FZ4A29X 10EZ4A32X 10DZ4A48X 10FZ4A24X 10EZ4A18X 10DZ4B55X 10DZ4A06X 10FZ4A02X 10EZ4A57X 10EZ4A24X 10EZ4A58X 10EZ4A06X 10FZ4A38X 10FZ4A03X 10EZ4A29X 10EZ4A08X 10EZ4A55X 10FZ4A36X 10EZ4A20X 10EZ4A31X 10DZ4B18X 10GZ4A40X 10FZ4A18X 10FZ4A39X 10DZ4B42X 10FZ4A31X 10EZ4A47X 10GZ4A44X 10GZ4A58X 10DZ4B51X 10GZ4A27X 10DZ4B30X 10FZ4A37X 10GZ4A01X 10GZ4A43X 10GZ4A38X 10GZ4A35X 10EZ4A48X 10GZ4A03X 10GZ4A08X 10GZ4A37X 10DZ4B41X 10GZ4A02X 10DZ4B31X 10DZ4A55X 10GZ4A76X 10GZ4A66X 10DZ4B20X 10FZ4A15X 10FZ4A01X 10GZ4A34X 10EZ4A10X 10FZ4A22X 10GZ4A73X 10EZ4A53X 10FZ4A21X 10GZ4A94X 10GZ4A06X 10GZ4A61X 10GZ4A78X 10EZ4A60X 10FZ4A13X 10GZ4A96X 10GZ4A04X 10FZ4A28X 10GZ4A11X 10EZ4A34X 10GZ4A59X 10EZ4A11X 10GZ4A05X 10FZ4A04X 10GZ4A18X 10EZ4A49X 10GZ4A54X 10GZ4A92X 10GZ4A90X 10GZ4A57X 10EZ4A40X 10FZ4A40X 10GZ4A63X 10DZ4A49X 10GZ4A41X 10GZ4A29X 10GZ4A83X 10GZ4B54X 10GZ4A70X 10GZ4A19X 10EZ4A23X 10FZ4A06X 10GZ4A95X 10FZ4A20X 10GZ4A30X 10GZ4A89X 10GZ4A72X 10GZ4A71X 10GZ4A12X 10GZ4B34X 10GZ4B18X 10GZ4A09X 10GZ4B22X 10GZ4A99X 10GZ4A93X 10GZ4A64X 10GZ4A77X 10FZ4A05X 10DZ4A59X 10GZ4A75X 10GZ4A98X 10GZ4B26X 10GZ4A33X 10GZ4B08X 10FZ4A32X 10GZ4B59X 10GZ4B38X 10GZ4B07X 10GZ4B44X 10GZ4B41X 10GZ4A69X 10GZ4A87X 10HZ4A02X 10GZ4B55X 10GZ4B28X 10HZ4A26X 10GZ4A91X 10HZ4A41X 10GZ4B52X 10HZ4A46X 10FZ4A35X 10GZ4B16X 10FZ4A09X 10HZ4A70X 10DZ4A12X 10GZ4B37X 10GZ4A42X 10DZ4B35X 10GZ4A20X 10HZ4A82X 10HZ4A49X 10GZ4A97X 10EZ4A59X 10HZ4A16X 10GZ4A21X 10GZ4A53X 10HZ4A07X 10HZ4A33X 10HZ4A81X 10GZ4B06X 10HZ4A19X 10HZ4A22X 10HZ4A83X 10HZ4A20X 10HZ4A21X 10HZ4A12X 10HZ4A04X 10DZ4B12X 10GZ4A07X 10HZ4A15X 10GZ4B01X 10HZ4A80X 10GZ4A46X 10HZ4A35X 10HZ4A39X 10GZ4B51X 10GZ4B12X 10HZ4A09X 10HZ4A57X 10GZ4B32X 10GZ4B57X 10HZ4A71X 10GZ4B10X 10HZ4A25X 10FZ4A07X 10GZ4B11X 10HZ4A64X 10IZ4B09X 10GZ4A81X 10GZ4B21X 10GZ4B53X 10IZ4A84X 10HZ4A11X 10JZ4A67X 10HZ4A05X 10HZ4A37X 10IZ4A64X 10GZ4B36X 10IZ4A38X 10GZ4B04X 10GZ4B35X 10HZ4A61X 10HZ4A28X 10HZ4A44X 10HZ4A23X 10IZ4A78X 10GZ4B61X 10GZ4A39X 10IZ4A91X 10HZ4A40X 10IZ4B05X 10IZ4A60X 10IZ4B14X 10IZ4A61X 10GZ4B25X 10GZ4B47X 10IZ4A92X 10IZ4B08X 10IZ4B07X 10HZ4A55X 10GZ4B45X 10GZ4B42X 10HZ4A69X 10IZ4A50X 10IZ4A85X 10GZ4A15X 10IZ4B17X 10HZ4A42X 10CZ4B06X 10HZ4A53X 10IZ4A79X 10HZ4A24X 10IZ4A69X 10IZ4A42X 10IZ4A96X 10IZ4A72X 10HZ4A17X 10IZ4B21X 10IZ4A73X 10IZ4A74X 10IZ4A31X 10JZ4A18X 10IZ4A77X 10IZ4A49X 10IZ4A57X 10IZ4A35X 10IZ4B16X 10IZ4B15X 10IZ4A46X 10GZ4A10X 10GZ4B03X 10IZ4A71X 10IZ4A43X 10JZ4A05X 10IZ4B06X 10JZ4A60X 10HZ4A45X 10JZ4A35X 10IZ4A40X 10IZ4A34X 10IZ4A93X 10HZ4A85X 10JZ4A11X 10IZ4B04X 10JZ4A54X 10JZ4A56X 10IZ4A67X 10GZ4A36X 10IZ4B01X 10HZ4A08X 10JZ4A12X 10JZ4A27X 10HZ4A56X 10JZ4A46X 10JZ4A78X 10JZ4A23X 10HZ4A79X 10JZ4A02X 10JZ4A89X 10JZ4A19X 10JZ4A82X 10JZ4A44X 10IZ4A76X 10IZ4A53X 10JZ4A90X 10JZ4A81X 10IZ4B12X 10GZ4B15X 10JZ4A80X 10JZ4A06X 10JZ4A53X 10JZ4A87X 10GZ4B60X 10JZ4A88X 10JZ4A17X 10HZ4A31X 10JZ4A72X 10JZ4A01X 10JZ4A16X 10IZ4A75X 10JZ4A07X 10HZ4A03X 10HZ4A54X 10JZ4A39X 10HZ4A13X 10JZ4A29X 10JZ4A65X 10JZ4A63X 10JZ4A69X 10JZ4A32X 10EZ4A22X 10JZ4A37X 10IZ4A66X 10JZ4A62X 10JZ4A34X 10JZ4A43X 10JZ4A42X 10IZ4A83X 10IZ4A59X 10JZ4B16X 10HZ4A34X 10JZ4A08X 10JZ4B17X 10JZ4B25X 10JZ4B10X 10JZ4B08X 10JZ4A13X 10JZ4B02X 10JZ4B24X 10JZ4A95X 10JZ4A25X 10JZ4A64X 10IZ4B13X 10JZ4B12X 10JZ4B31X 10JZ4B29X 10JZ4A74X 10JZ4A76X 10JZ4B26X 10JZ4B30X 10JZ4A97X 10JZ4B40X 10JZ4A98X 10JZ4B36X 10JZ4A40X 10JZ4B06X 10GZ4A50X 10JZ4B23X 10JZ4C20X 10JZ4C09X 10JZ4B39X 10JZ4B73X 10HZ4A50X 10JZ4C26X 10JZ4B13X 10JZ4B42X 10JZ4B78X 10HZ4A65X 10JZ4C17X 10JZ4B72X 10JZ4B68X 10JZ4C24X 10GZ4B05X 10JZ4B11X 10JZ4B65X 10JZ4B66X 10JZ4C32X 10IZ4A44X 10JZ4C18X 10JZ4B34X 10JZ4B53X 10JZ4B22X 10JZ4B43X 10JZ4C13X 10JZ4B52X 10GZ4A79X 10JZ4B38X 10JZ4B09X 10JZ4A58X 10JZ4C05X 10JZ4C02X 10JZ4B03X 10JZ4B37X 10JZ4B88X 10JZ4B90X 10JZ4C01X 10JZ4B07X 10JZ4B71X 10JZ4C25X 10JZ4A26X 10HZ4A66X 10JZ4B67X 10JZ4C21X 10JZ4B99X 10JZ4C23X 10JZ4A75X 10JZ4C11X 10JZ4A83X 10JZ4C27X 10KZ4A01X 10JZ4B76X 10KZ4A39X 10JZ4B58X 10FA4A69X 10JZ4B74X 10KZ4A27X 10JZ4C30X 10HZ4A63X 10JZ4B59X 10GZ4B13X 10JZ4A20X 10JZ4A52X 10KZ4A08X 10JZ4B50X 10JZ4B70X 10JZ4B98X 10JZ4B04X 10IZ4A82X 10JZ4B80X 10KZ4A09X 10JZ4B45X 10GZ4B24X 10KZ4A06X 10KZ4A18X 10KZ4A23X 10JZ4A99X 10JZ4C14X 10KZ4A20X 10JZ4B89X 10KZ4A17X 10KZ4A40X 10KZ4A05X 10KZ4A26X 10KZ4A19X 10KZ4A30X 10JZ4C28X 10JZ4B79X 10JZ4A85X 10JZ4B96X 10KZ4A41X 10KZ4A22X 10JZ4C31X 10IZ4A65X 10JZ4A84X 10KZ4A29X 10LZ4A87X 10KZ4A25X 10KZ4A45X 10JZ4B44X 10JZ4B87X 10KZ4A33X 10KZ4A42X 10KZ4A31X 10JZ4B63X 10JZ4A91X 10LZ4A48X 10KZ4A14X 10JZ4B32X 10LZ4A38X 10LZ4A74X 10LZ4A43X 10JZ4B57X 10JZ4A47X 10JZ4B94X 10LZ4A58X 10LZ4A46X 10LZ4A75X 10KZ4A04X 10LZ4A64X 10JZ4B61X 10LZ4A84X 10LZ4A67X 10JZ4C04X 10LZ4A45X 10LZ4A39X 10AA4A44X 10LZ4A55X 10LZ4A40X 10LZ4A61X 10LZ4A60X 10KZ4A10X 10KZ4A11X 10LZ4A66X 10LZ4A52X 10JZ4A33X 10LZ4A69X 10JZ4A36X 10LZ4A90X 10LZ4A82X 10AA4A38X 10JZ4B62X 10LZ4A68X 10LZ4A41X 10LZ4A81X 10KZ4A02X 10AA4A06X 10LZ4A37X 10LZ4A49X 10KZ4A32X 10LZ4A80X 10LZ4A85X 10AA4A34X 10LZ4A53X 10KZ4A38X 10LZ4A59X 10LZ4A76X 10JZ4A96X 10LZ4A77X 10JZ4C15X 10LZ4A50X 10LZ4A78X 10AA4A58X 10AA4A79X 10LZ4A94X 10AA4A27X 10AA4A32X 10HZ4A58X 10AA4A71X 10JZ4C29X 10AA4A24X 10LZ4A51X 10AA4A85X 10KZ4A12X 10LZ4A88X 10AA4A12X 10AA4A65X 10JZ4B54X 10AA4A40X 10AA4A46X 10AA4A19X 10AA4A55X 10AA4A28X 10AA4A14X 10AA4A15X 10AA4A21X 10LZ4A42X 10AA4A41X 10LZ4A44X 10AA4A05X 10AA4A77X 10AA4A49X 10IZ4A55X 10JZ4B64X 10JZ4B60X 10AA4A09X 10AA4A07X 10AA4A78X 10JZ4B49X 10KZ4A03X 10AA4A17X 10AA4A47X 10KZ4A28X 10AA4A01X 10AA4A59X 10LZ4A93X 10AA4A67X 10AA4A86X 10AA4A30X 10KZ4A36X 10LZ4A62X 10LZ4A95X 10AA4A03X 10AA4A11X 10AA4A72X 10AA4A90X 10AA4A52X 10AA4A83X 10AA4A31X 10AA4A10X 10KZ4A24X 10AA4A76X 10AA4A51X 10IZ4B11X 10AA4A63X 10IZ4A88X 10AA4A60X 10LZ4A89X 10BA4A54X 10AA4A04X 10AA4A20X 10AA4A13X 10AA4A69X 10BA4A30X 10BA4A40X 10BA4A36X 10LZ4A72X 10AA4A08X 10LZ4A91X 10IZ4A33X 10BA4A79X 10BA4A74X 10AA4A57X 10AA4A02X 10BA4A62X 10AA4A50X 10KZ4A16X 10BA4A38X 10BA4A76X 10BA4A28X 10AA4A61X 10BA4A64X 10BA4A75X 10BA4A50X 10AA4A39X 10BA4A34X 10AA4A81X 10AA4A54X 10AA4A80X 10KZ4A13X 10LZ4A54X 10BA4A68X 10AA4A23X 10BA4A57X 10LZ4A92X 10BA4A49X 10BA4A60X 10AA4A26X 10BA4A47X 10AA4A36X 10BA4A72X 10JZ4C22X 10JZ4B47X 10AA4A87X 10AA4A29X 10BA4A65X 10AA4A45X 10AA4A88X 10BA4A70X 10BA4A39X 10BA4A71X 10AA4A42X 10AA4A56X 10JZ4A59X 10JZ4A15X 10EZ4A42X 10FZ4A08X 10CA4A43X 10CA4A44X 10CA4A23X 10BA4A84X 10CA4A05X 10BA4A41X 10BA4A82X 10CA4A11X 10CA4A08X 10BA4A51X 10IZ4A68X 10BA4A55X 10CA4A30X 10BA4A33X 10BA4A66X 10CA4A01X 10BA4A52X 10CA4A10X 10BA4A29X 10BA4A78X 10CA4A07X 10CA4A45X 10JZ4A14X 10CA4A38X 10CA4A17X 10CA4A53X 10CA4A16X 10CA4A94X 10DA4A48X 10CA4A04X 10CA4A42X 10CA4A39X 10BA4A35X 10CA4A82X 10BA4A53X 10BA4A58X 10CA4A13X 10CA4A18X 10CA4A19X 10CA4A02X 10CA4A83X 10CA4A46X 10CA4A09X 10CA4A26X 10CA4A80X 10CA4A63X 10BA4A31X 10CA4A57X 10CA4A49X 10CA4A62X 10CA4A61X 10BA4A81X 10CA4A87X 10CA4A89X 10CA4A25X 10BA4A85X 10CA4A56X 10CA4A88X 10CA4A60X 10CA4A85X 10DA4A01X 10CA4A97X 10DA4A21X 10CA4A95X 10DA4A31X 10CA4A93X 10CA4A74X 10DA4A53X 10DA4A49X 10CA4A73X 10CA4A64X 10CA4A84X 10CA4A67X 10DA4A52X 10DA4A09X 10CA4A69X 10DA4A69X 10BA4A27X 10DA4A02X 10BA4A83X 10DA4A62X 10DA4A07X 10DA4A70X 10DA4A39X 10DA4A41X 10DA4A67X 10DA4A66X 10DA4A58X 10DA4A54X 10DA4A35X 10DA4A43X 10CA4A66X 10CA4A34X 10DA4A42X 10JZ4B84X 10CA4A58X 10DA4A71X 10DA4A44X 10DA4A30X 10CA4A14X 10CA4A70X 10EA4A65X 10EA4A71X 10EA4A26X 10EA4A58X 10EA4A73X 10EA4A47X 10DA4A68X 10EA4A78X 10EA4A11X 10DA4A14X 10DA4A57X 10DA4A17X 10DA4A74X 10DA4A34X 10DA4A05X 10EA4A25X 10EA4A33X 10DA4A72X 10EA4A12X 10DA4A37X 10EA4A01X 10CA4A90X 10EA4A21X 10EA4A24X 10EA4A77X 10EA4A30X 10CA4A50X 10DA4A73X 10EA4A62X 10EA4A53X 10DA4A12X 10CA4A68X 10DA4A47X 10EA4A07X 10EA4A15X 10DA4A15X 10EA4A64X 10EA4A63X 10CA4A03X 10EA4A35X 10EA4A27X 10AA4A37X 10CA4A12X 10CA4A78X 10EA4A32X 10EA4A56X 10EA4A03X 10DA4A27X 10EA4A18X 10EA4A44X 10EA4A42X 10DA4A60X 10EA4A28X 10DA4A63X 10DA4A18X 10EA4A06X 10EA4A68X 10EA4A38X 10FA4A90X 10FA4A81X 10BA4A43X 10EA4A08X 10EA4A34X 10EA4A59X 10DA4A32X 10FA4A39X 10FA4A94X 10EA4A13X 10EA4A49X 10FA4A79X 10DA4A59X 10FA4B02X 10FA4A59X 10FA4A35X 10CA4A92X 10EA4A69X 10FA4A53X 10FA4B10X 10FA4A70X 10FA4A46X 10FA4A83X 10EA4A04X 10EA4A46X 10DA4A26X 10FA4A49X 10FA4A40X 10FA4A76X 10CA4A35X 10FA4A97X 10CA4A71X 10FA4B06X 10FA4A43X 10FA4A37X 10FA4B01X 10FA4A34X 10EA4A20X 10FA4A32X 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2MA00190X 2MA00125X 2MA00259X 10AD4A02X 10DC4C42X 10KC4A46X 10HC4C91X 10KB4A05X 10KB4A26X 2MA00137X 10AD4A76X 2MA00492X 2MA00546X 10AD4A29X 2MA00314X 2MA00229X 2MA00370X 2MA00457X 2MA00398X 2MA00642X 2MA00365X 2MA00471X 2MA00333X 10BD4B06X 10BD4A05X 2MA00377X 2MA00469X 2MA00521X 10AD4A42X 10AD4A56X 2MA00281X 2MA00083X 10BD4A93X 10KC4A64X 2MA00141X 10HC4D05X 2MA00180X 10AD4A43X 10IC4B92X 2MA00061X 10BD4A20X 10AD4A37X 10KC4B08X 2MA00293X 2MA00484X 2MA00358X 2MA00331X 10KC4A89X 10BD4A66X 2MA00446X 2MA00488X 2MA00273X 2MA00275X 2MA00438X 2MA00027X 2MA00396X 10LC4A60X 2MA00159X 10BD4A98X 2MA00540X 10LC4A64X 10BD4A40X 2MA00436X 2MA00636X 2MA00418X 10LC4A05X 2MA00304X 2MA00598X 2MA00483X 2MA00021X 2MA00384X 2MA00505X 2MA00514X 2MA00023X 2MA00667X 2MA00470X 2MA00649X 2MA00416X 2MA00602X 2MA00475X 2MA00623X 2MA00047X 2MA00228X 10LC4A00X 2MA00600X 2MA00635X 2MA00250X 10AD4A87X 10AD4A95X 10LC4A56X 2MA00500X 10LC4A02X 10KC4B22X 10LC4A11X 10LC4A54X 10KC4A60X 2MA00080X 10AD4A19X 2MA00184X 10LC4A80X 2MA00400X 2MA00640X 2MA00170X 2MA00217X 2MA00092X 2MA00605X 2MA00597X 2MA00588X 10BD4A41X 10LC4A35X 10LC4A33X 10LC4A37X 2MA00064X 2MA00208X 2MA00338X 2MA00359X 2MA00345X 10LC4A26X 2MA00577X 2MA00621X 2MA00629X 2MA00630X 2MA00627X 2MA00518X 2MA00603X 2MA00097X 2MA00620X 2MA00493X 2MA00562X 2MA00013X 2MA00607X 2MA00719X 2MA00553X 10AD4A77X 2MA00596X 10BD4A27X 2MA00329X 2MA00369X 2MA00302X 2MA00371X 2MA00306X 2MA00305X 2MA00485X 10LC4A68X 10AD4A14X 2MA00212X 2MA00593X 2MA00346X 2MA00558X 2MA00068X 10AD4A60X 2MA00494X 2MA00666X 2MA00086X 2MA00445X 2MA00452X 2MA00735X 2MA00106X 2MA00174X 2MA00350X 10DC4A94X 2MA00741X 2MA00255X 10AD4A01X 2MA00545X 2MA00737X 2MA00300X 2MA00187X 10AD4A71X 2MA00616X 2MA00099X 2MA00622X 2MA00425X 2MA00618X 2MA00311X 2MA00463X 2MA00381X 10BD4A39X 2MA00426X 2MA00335X 2MA00740X 2MA00775X 2MA00460X 2MA00303X 2MA00328X 2MA00310X 2MA00581X 10DB4A28X 10AD4A16X 2MA00564X 2MA00617X 2MA00399X 2MA00764X 2MA00394X 2MA00434X 2MA00464X 2MA00584X 2MA00592X 2MA00285X 2MA00715X 2MA00683X 2MA00665X 2MA00717X 2MA00430X 2MA00279X 2MA00739X 2MA00352X 2MA00755X 2MA00417X 2MA00420X 2MA00196X 2MA00225X 2MA00684X 2MA00267X 2MA00714X 2MA00222X 2MA00439X 2MA00481X 2MA00405X 2MA00647X 2MA00326X 2MA00482X 10KC4A55X 2MA00165X 10AD4A57X 2MA00344X 2MA00193X 2MA00143X 10AD4A15X 2MA00316X 2MA00131X 2MA00637X 2MA00372X 2MA00606X 2MA00624X 2MA00609X 10BD4A16X 2MA00610X 2MA00501X 2MA00613X 2MA00503X 2MA00645X 10BD4B16X 2MA00589X 10LC4B00X 10LC4A23X 2MA00164X 2MA00156X 2MA00619X 2MA00626X 2MA00502X 2MA00746X 2MA00301X 2MA00241X 10IA4B74X 10HA4A01X 2MA00428X 2MA00676X 2MA00643X 2MA00427X 2MA00465X 2MA00435X 2MA00685X 2MA00652X 10AD4A45X 2MA00788X 2MA00742X 2MA00736X 2MA00802X 2MA00807X 2MA00679X 2MA00487X 2MA00625X 2MA00724X 2MA00559X 2MA00767X 2MA00519X 2MA00567X 10DC4B14X 2MA00517X 2MA00513X 2MA00349X 10LC4A41X 2MA00441X 10EC4A65X 2MA00472X 2MA00875X 2MA00543X 2MA00364X 2MA00836X 2MA00854X 2MA00272X 2MA00548X 2MA00863X 2MA00761X 2MA00594X 2MA00762X 2MA00440X 2MA00801X 2MA00511X 2MA00072X 2MA00175X 10BD4A84X 2MA00320X 2MA00638X 2MA00815X 2MA00321X 2MA00834X 2MA00646X 2MA00913X 2MA00362X 2MA00943X 2MA00750X 2MA00129X 2MA00114X 2MA00612X 2MA00910X 2MA00803X 2MA00738X 2MA00826X 2MA00659X 10LC4A66X 2MA00720X 10KC4B45X 2MA00655X 2MA00008X 2MA00689X 2MA00672X 2MA00615X 2MA00633X 2MA00656X 2MA00050X 2MA00183X 2MA00410X 2MA00657X 2MA00820X 2MA00429X 2MA00437X 10AD4A50X 2MA00525X 2MA00806X 2MA00828X 2MA00853X 2MA00126X 2MA00710X 2MA00781X 2MA00891X 2MA00532X 2MA00734X 2MA00682X 2MA00758X 2MA00952X 10EC4A87X 2MA00421X 2MA00942X 2MA00920X 2MA00016X 2MA00019X 2MA00650X 10AD4A17X 10AD4A40X 2MA00687X 2MA00855X 2MA00366X 2MA00547X 2MA00324X 2MA00590X 2MA00918X 2MA00658X 2MA00889X 2MA00138X 2MA00431X 2MA00150X 2MA00578X 2MA00641X 10HC4B24X 2MA00938X 2MA00874X 2MA00872X 2MA00911X 2MA00508X 2MA00688X 2MA00604X 2MA00709X 2MA00495X 2MA00160X 2MA00664X 2MA00565X 2MA00404X 2MA00315X 2MA00907X 2MA00848X 2MA00506X 2MA00312X 2MA00694X 2MA00959X 2MA00927X 2MA00286X 2MA00089X 2MA00849X 2MA00835X 2MA00878X 2MA00005X 2MA00932X 2MA00017X 2MA00595X 10AD4A67X 10DZ4B57X 2MA00541X 2MA00573X 2MA00700X 2MA00530X 2MA00376X 2MA00591X 2MA00583X 2MA00054X 2MA00760X 2MA00549X 2MA00906X 2MA00837X 2MA00939X 2MA00712X 2MA00674X 2MA00670X 2MA00561X 2MA00799X 2MA00915X 2MA00789X 2MA00873X 2MA00846X 2MA00692X 2MA00206X 2MA00078X 2MA00713X 2MA00999X 2MA00847X 2MA00996X 2MA00928X 2MA00804X 2MA00147X 2MA00136X 2MA00127X 2MA00132X 2MA00497X 2MA00130X 2MA00354X 2MA00557X 2MA00251X 2MA00926X 2MA01004X 2MA01005X 2MA00995X 2MA00691X 2MA01100X 2MA00587X 2MA00507X 2MA00648X 2MA00681X 2MA00897X 2MA00651X 2MA00725X 2MA00852X 2MA00884X 2MA00231X 2MA00882X 2MA00890X 2MA00917X 2MA01088X 2MA00654X 2MA00813X 2MA00668X 2MA00690X 2MA00857X 2MA00866X 2MA00859X 2MA00902X 2MA00697X 2MA01026X 2MA00929X 2MA01135X 2MA00705X 2MA00701X 2MA00699X 2MA00916X 2MA00491X 2MA00898X 2MA00842X 2MA00825X 2MA01073X 2MA00753X 2MA00780X 2MA00935X 2MA00919X 2MA00489X 2MA00731X 2MA01137X 10JB4C90X 10GB4A65X 2MA00258X 2MA00340X 2MA00909X 2MA00001X 2MA00563X 2MA00529X 2MA00930X 2MA01034X 2MA00537X 2MA00695X 2MA00711X 2MA00109X 2MA01013X 2MA01011X 2MA00830X 2MA00238X 2MA00669X 2MA00515X 2MA00660X 2MA00931X 2MA00908X 10AD4A00X 10BD4A79X 2MA00790X 2MA01039X 2MA00800X 2MA00075X 2MA01040X 10BD4A46X 2MA00392X 2MA00388X 2MA00018X 2MA01115X 2MA00924X 2MA00294X 2MA00533X 2MA00794X 2MA00966X 2MA00840X 2MA00841X 2MA00671X 2MA00941X 2MA00582X 2MA00383X 2MA01081X 2MA00777X 2MA00809X 2MA01027X 2MA00833X 2MA00071X 2MA00976X 2MA00795X 2MA00851X 2MA00554X 2MA01244X 2MA01236X 2MA00870X 2MA01001X 10BD4B04X 2MA00308X 2MA01093X 2MA00940X 2MA01148X 2MA00796X 2MA00036X 10JB4D33X 2MA00967X 2MA01084X 2MA00325X 2MA01050X 2MA01054X 2MA00084X 2MA00698X 2MA01126X 2MA01227X 2MA00082X 2MA01209X 2MA01215X 2MA00040X 2MA01066X 2MA00661X 2MA01224X 2MA00933X 2MA01143X 2MA01067X 2MA00980X 2MA00973X 2MA01219X 2MA00011X 2MA01118X 2MA00007X 2MA00423X 2MA01006X 2MA01198X 2MA01196X 2MA01074X 2MA00818X 2MA00572X 2MA00579X 2MA01264X 2MA01136X 10LB4A84X 2MA00678X 2MA00675X 2MA00142X 2MA00121X 2MA00912X 2MA00749X 2MA00628X 2MA00580X 2MA00744X 2MA00839X 10JZ4A24X 2MA00903X 2MA00754X 2MA01029X 2MA00831X 2MA01032X 2MA01033X 2MA00787X 2MA00769X 2MA00504X 2MA01147X 2MA01127X 2MA01165X 2MA00576X 2MA01212X 2MA01028X 2MA00843X 2MA00566X 2MA00079X 2MA00401X 2MA00945X 2MA01106X 2MA00822X 2MA01052X 2MA01248X 2MA00330X 2MA00144X 2MA01020X 2MA01025X 2MA01078X 2MA01065X 2MA00486X 2MA01229X 2MA00991X 2MA00962X 2MA01024X 2MA00949X 2MA01114X 2MA00535X 2MA00900X 2MA01058X 2MA00415X 2MA01259X 2MA00960X 2MA00871X 2MA00765X 2MA00555X 2MA00516X 2MA00608X 2MA01207X 2MA00934X 2MA00702X 2MA00704X 2MA00953X 2MA01153X 2MA00793X 2MA00858X 2MA01133X 2MA01043X 2MA00821X 2MA00947X 2MA00885X 2MA01201X 2MA00728X 2MA01246X 2MA00031X 2MA00073X 2MA01221X 2MA01222X 2MA01134X 2MA00252X 2MA01083X 2MA00823X 2MA01124X 2MA00961X 2MA00979X 2MA01049X 2MA01202X 10CC4A30X 2MA01019X 2MA00838X 2MA00792X 2MA01056X 2MA01002X 2MA01000X 2MA00523X 2MA01307X 2MA01030X 2MA01087X 2MA00496X 2MA00524X 2MA00970X 2MA01149X 2MA00531X 2MA01239X 2MA00955X 2MA00896X 2MA01051X 2MA01267X 2MA01247X 2MA00768X 2MA00899X 2MA01035X 2MA01018X 2MA01023X 2MA00922X 2MA00389X 2MA00954X 2MA01142X 2MA01062X 2MA00707X 2MA00983X 2MA00332X 2MA00322X 2MA01038X 2MA01296X 2MA00757X 2MA01257X 2MA01297X 2MA01057X 2MA01368X 2MA01331X 2MA01085X 2MA01301X 2MA01249X 2MA00407X 2MA01086X 2MA00869X 2MA01295X 2MA01145X 2MA01014X 2MA01003X 2MA00509X 2MA00791X 2MA00453X 2MA01388X 2MA01412X 2MA01046X
• 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: 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.