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    Mytrex, INC.

    FDA UDI
    Rescue Alert·00854241006150·Personal Emergency Response System (Landline unit)

    MODEL MF..D & MX..D PACEMAKER LEADS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    LW TWINPIN,5LD,PINCH,MXD,INTERMED

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828140324·LW TWINPIN,5LD,PINCH,MXD,INTERMED

    LW INTELIV,5LD,GRP,PINCH,MXD,INTERMED

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828140362·LW INTELIV,5LD,GRP,PINCH,MXD,INTERMED

    LW MULTILINK,5LD,GRP,PINCH,MXD,INTERMED

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828140232·LW MULTILINK,5LD,GRP,PINCH,MXD,INTERMED

    LW PLP2000,5LD,TELE,PINCH,29"-51"MXD.

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828130769·LW PLP2000,5LD,TELE,PINCH,29"-51"MXD.

    LW INTELL,5LD,TELE,PINCH,MXD,INTERMED

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828140416·LW INTELL,5LD,TELE,PINCH,MXD,INTERMED

    LW TWINPIN,5LD,SNAP,29"-51"MXD,INTERMED

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828140041·LW TWINPIN,5LD,SNAP,29"-51"MXD,INTERMED

    LW PLP2000,5LD,GRP,PINCH,29"-51"MXD,A

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828130714·LW PLP2000,5LD,GRP,PINCH,29"-51"MXD,A

    MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)

    FDA 510(k)
    FDA Class 2 ·Radiology

    LW MULTILINK,5LD,GRP,PINCH,29-51"MXD,A

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828130806·LW MULTILINK,5LD,GRP,PINCH,29-51"MXD,A

    BD COR¿ MX

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·April 16, 2025

    UNSPECIFIED BD PRIMARY ALARIS SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·January 14, 2021

    Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVOLUTR-23 TAV JPN MX, VLV EVOLUTR-23 GREY 29L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 7L MX, VLV EVOLUTR-23 TAV EVOLUT R CE 26L MX, VLV EVOLUTR-23 TAV CA 2Y MX, VLV EVOLUTR-23 GREY 6L COMM OUS, VLV EVOLUTR-23-US TAV 23 US COMM MX; b. EVOLUTR-23-C, Labeled as VLV EVOLUTR-23-C TAV EVOLUT R US IDE MEX; c. EVOLUTR-23-US, Labeled as VLV EVOLUTR-23-US GREY COMM US, VLV EVOLUTR-23-US TAV 23 US COMM MX; d. EVOLUTR-26, Labeled as VLV EVOLUTR-26 TAV EVOLUT R CE 29L MX VLV EVOLUTR-26 VT IR 6L COMM OUS, VLV EVOLUTR-26 TAV EVOLUT R CE 7L MX, LV EVOLUTR-26 TAV CE AU 2Y MX, VLV EVOLUTR-26 TAV JPN MX, VLV EVOLUTR-26 GREY 29L COMM OUS, VLV EVOLUTR-26-US TAV 26 US COMM MX, VLV EVOLUTR-26 TAV CLN OUS MX, VLV EVOLUTR-26 TAV CA 2Y MX, VLV EVOLUTR-26 TAV CE CA 2Y MX, VLV EVOLUTR-26 GREY 6L COMM OUS; e. EVOLUTR-26-C, Labeled as VLV EVOLUTR-26-C TAV EVOLUT R US IDE MEX, VLV EVOLUTR-26-C TAV CLN US MX; f. EVOLUTR-26-US, Labeled as VLV EVOLUTR-26 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-26-US GREY COMM US, VLV EVOLUTR-26-US TAV 26 US COMM MX; g. EVOLUTR-29, Labeled as VLV EVOLUTR-29 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-29 GREY 6L COMM OUS, VLV EVOLUTR-29 VT IR 6L COMM OUS, VLV EVOLUTR-29 TAV CE AU 2Y MX, VLV EVOLUTR-29 TAV JPN MX, VLV EVOLUTR-29 GREY 29L COMM OUS, VLV EVOLUTR-29 TAV EVOLUT R CE 7L MX, VLV EVOLUTR-29 TAV CLN OUS MX, VLV EVOLUTR-29 TAV CA 2Y MX, VLV EVOLUTR-29 TAV CE CA 2Y MX, VLV EVOLUTR-29-US TAV 29 US COMM MX; h. EVOLUTR-29-C, Labeled as VLV EVOLUTR-29-C TAV EVOLUT R US IDE MEX, LV EVOLUTR-29-C TAV CLN US MX, VLV EVOLUTR-29-US TAV 29 US COMM MX; i. EVOLUTR-29-US, Labeled as VLV EVOLUTR-29-US GREY COMM US, VLV EVOLUTR-29-US TAV 29 US COMM MX, VLV EVOLUTR-29 TAV EVOLUT R CE 29L MX; j. EVOLUTR-34, Labeled as VLV EVOLUTR-34 BLUE 29L COMM OUS, VLV EVOLUTR-34 VT IR 6L COMM OUS, VLV EVOLUTR-34 BLUE 6L COMM OUS, VLV EVOLUTR-34 TAV CE AU 2Y MX, VLV EVOLUTR-34 TAV JPN MX, VLV EVOLUTR-34 TAV CLN OUS MX, VLV EVOLUTR-34 TAV CA 2Y MX, VLV EVOLUTR-34 TAV CE CA 2Y MX, VLV EVOLUTR-34 TAV EVOLUT R CE 29L 1Y MX, VLV EVOLUTR-34 TAV EVO R CE 29L 2Y MX SA, DRAPE 9732722 TUBE STERILE O-ARM 20PK; k. EVOLUTR-34-C, Labeled as VLV EVOLUTR-34-C TAV EVOLUT R US IDE MX, VLV EVOLUTR-34-C TAV CLN US MX; l. EVOLUTR-34-US, Labeled as VLV EVOLUTR-34-US BLUE COMM US, VLV EVOLUTR-34-US TAV 34 US COMM MX, VLV EVOLUTR-34 TAV EVOLUT R CE 29L 1Y MX, VLV EVOLUTR-34-US TAV 34 US COMM MX SA.

    FDA Enforcement
    Class II ·Terminated·Medtronic Heart Valves Division·December 16, 2020

    LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code MXD·March 30, 2026

    LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code MXD·March 30, 2026

    Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code MXD·September 6, 2024

    ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code MXD·November 3, 2023

    Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code MXD·May 14, 2021

    Medtronic Reveal LINQ LNQ11 / PA96000

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code MXD·June 1, 2021