FDA Faib Cov Teeb Meem Tswj Lub Plawv Impella Ua Qhov Teeb Meem Loj Tshaj Plaws Qib Kuv Rov Qab Nco: Kwv yees li 900 Chav Yuav Tsum Tshem Tawm Rau Kev Pabcuam
Lub Koom Haum Saib Xyuas Khoom Noj thiab Tshuaj (FDA) tau muab qhov teeb meem hloov tshiab uas cuam tshuam rau Abiomed's Impella lub twj tso kua mis plawv ua Class I rov qab los, hom kev rov qab los ntawm lub koom haum uas hnyav tshaj plaws, txhais tau tias kev siv cov khoom siv no txuas ntxiv mus yuav ua rau raug mob hnyav lossis tuag. FDA tau tshaj tawm ib qho kev ceeb toom ntxov txog qhov teeb meem no thaum lub Cuaj Hli; raws li Cardiovascular Business, uas tau hais txog FDA cov ntaub ntawv rov qab los tshiab tshaj plaws thaum Lub Kaum Hli 29, qhov teeb meem no tam sim no tau raug cais ua Class I.
Qhov kev hu rov qab tsuas yog suav nrog cov khoom tshwj xeeb ntawm peb lub qauv tswj hwm, kwv yees li 900 units tag nrho: 428 Automated Impella Controllers ntim, 179 Impella Optical Controllers ntim, thiab 293 Impella Connect Optical AIC units. Cov khoom siv cuam tshuam yuav tsum tau tshem tawm ntawm qhov chaw uas lawv siv lossis muag kom txog thaum lawv tuaj yeem kho tau; yog tias tsim nyog tiag tiag kom ntseeg tau tias tus neeg mob tau txais kev kho mob, txawm li cas los xij, lawv tseem tuaj yeem siv tau.
Hauv nws qhov kev ceeb toom thaum ntxov, FDA tau hais tias kev tshuaj xyuas rov qab ntawm cov ntaub ntawv kev pabcuam tau txheeb xyuas qee cov Impella maub los uas xav tau kho vajtse, firmware, thiab / lossis software hloov tshiab. Cov teeb meem zoo suav nrog kev ua tsis tiav los paub txog lub tshuab ntxuav thaum lub sijhawm teeb tsa lossis hloov pauv, lub pob uas lo thiab tsis txhim khu kev qha uas tuaj yeem cuam tshuam rau tus neeg teb xov tooj lub peev xwm los xaiv thiab lees paub cov ntawv qhia zaub mov thiab tej zaum ua rau poob kev tswj hwm ntawm lub console, kev tsis ruaj khov uas tuaj yeem ua rau pib tsis ua haujlwm, thiab lwm yam teeb meem software.
Yog tsis muaj cov kev hloov tshiab, FDA tau hais tias, cov neeg mob yuav ntsib kev ncua sijhawm ntawm kev kho mob, tsis txaus lossis poob kev txhawb nqa hemodynamic, thiab lwm yam teeb meem loj. Abiomed tau xa ib tsab ntawv rau txhua tus neeg siv khoom cuam tshuam rau lub Cuaj Hlis 18, 2026, thiab nws pab neeg pabcuam yuav tiv tauj cov neeg siv khoom los sib koom tes tshem tawm, hloov tshiab, thiab xa rov qab cov khoom siv.
Txij li thaum lub Cuaj Hlis 8, 2026, Abiomed tsis tau tshaj tawm tias muaj kev raug mob hnyav lossis kev tuag cuam tshuam nrog qhov teeb meem no. Thaum tos kev pabcuam los ntawm Abiomed, cov khoom muag hauv tsev kho mob tuaj yeem siv txuas ntxiv mus kom ntseeg tau tias muaj kev saib xyuas txuas ntxiv mus. Cov neeg siv khoom hauv Tebchaws Meskas uas muaj kev tsis haum tshuaj, teeb meem zoo, lossis cov lus nug tuaj yeem tiv tauj Abiomed Field Service Team ntawm 1-800-422-8666, xaiv 3.
Lub Automated Impella Controller yog lub interface tswj hwm tus neeg siv tseem ceeb rau Impella catheters; nws tswj lub catheter thiab saib xyuas nws rau lub tswb ceeb toom. Kev kho mob Impella lub hom phiaj yog kom txo qhov ua haujlwm ntawm lub plawv thiab muab kev txhawb nqa kev ncig ntshav kom lub plawv muaj sijhawm rov zoo. Abiomed tam sim no yog ib feem ntawm Johnson & Johnson MedTech, uas tau yuav lub tuam txhab hauv xyoo 2022 rau kwv yees li $ 16.6 billion. Johnson & Johnson tau hais tias nws tau ua haujlwm ze nrog FDA ntawm kev tshuaj xyuas rov qab los siv kev txhim kho qhov system zoo, thiab tias cov khoom muag hauv tsev kho mob tuaj yeem txuas ntxiv siv, nrog rau cov tswb ceeb toom uas twb muaj lawm, kev saib xyuas, thiab kev txo qis, thaum cov kev hloov kho tshiab tsim nyog tau siv.
Qhov teeb meem hloov tshiab no txawv ntawm kev rov qab hu xov tooj ntawm Abiomed uas tau pib thaum Lub Yim Hli vim yog qhov ua tsis tiav ntawm cov khoom siv; FDA tswj cov nplooj ntawv sib cais rau ob qhov kev rov qab hu, thiab cov tsev kho mob yuav tsum txheeb xyuas cov khoom siv nrog cov lej serial thiab nplooj ntawv FDA sib xws.
Qhov chaw: GSM · Tebchaws Meskas (Qhov kev tshaj tawm lus Askiv · Qhov kev tshaj tawm lus Suav qub)
Duab: 图：美国食品药品监管局（FDA）白橡树园区一号大楼。GSM联邦机构固定图库照片，经 Wikimedia Commons，公共领域。 / Photo: Building 1 of the U.S. Food and Drug Administration White Oak campus. GSM federal agency library photo, via Wikimedia Commons, public domain.
