Ventricular (assist) bypass
FDA product code DSQ · Class 3 · 141 devices · 57,750 reports · 9,870 deaths reported · 62 devices named in recalls
- Thoratec® HeartMate 3™ 106524USThoratec Corporation · Ventricular (Assisst) Bypass7 recalls5,096 deaths16,478 reports
- THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) 106015Thoratec Corporation · Ventricular (Assisst) Bypass2 recalls2,141 deaths8,000 reports
- Thoratec® HeartMate 3™ 106531USThoratec Corporation · Ventricular (Assisst) Bypass1 recall11 deaths4,646 reports
- HVAD Pump Implant Kit 1103Heartware Inc. · Ventricular (Assist) Bypass6 recalls424 deaths2,952 reports
- HVAD® Pump Implant Kit (Enhanced) 1103Heartware Inc. · Ventricular (Assisst) Bypass4 recalls573 deaths2,807 reports
- HVAD® Pump Implant Kit 1103Heartware Inc. · Ventricular (Assisst) Bypass4 recalls666 deaths2,737 reports
- HVAD® Controller 1420Heartware Inc. · Ventricular (Assisst) Bypass5 recalls14 deaths2,161 reports
- HEARTMATE®, MOBILE POWER UNIT, NA 107754Thoratec Corporation · Ventricular (Assisst) Bypass1 death2,098 reports
- HeartWare® Controller 1403USHeartware Inc. · Ventricular (Assisst) Bypass3 recalls10 deaths1,495 reports
- HeartWare® Battery 1650DEHeartware Inc. · Ventricular (Assisst) Bypass1 recall1,126 reports
- THORATEC® HEARTMATE II®, SYSTEM CONTROLLER 106762Thoratec Corporation · Ventricular (Assisst) Bypass1 recall6 deaths1,101 reports
- THORATEC® HEARTMATE II®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) 104911Thoratec Corporation · Ventricular (Assisst) Bypass1 recall451 deaths1,092 reports
- HeartWare® Controller 1403USHeartware Inc. · Ventricular (Assisst) Bypass1 recall5 deaths898 reports
- HeartWare® Battery 1650Heartware Inc. · Ventricular (Assisst) Bypass3 recalls740 reports
- Thoratec® HeartMate 3™ VAD Modular Cable 106525USThoratec Corporation · Ventricular (Assisst) Bypass844 reports
- THORATEC® HEARTMATE II®, LVAS IMPLANT KIT 107801Thoratec Corporation · Ventricular (Assisst) Bypass2 recalls217 deaths721 reports
- HeartWare® Battery 1650DEHeartware Inc. · Ventricular (Assist) Bypass2 recalls606 reports
- HeartWare® Battery 1650DEHeartware Inc. · Ventricular (Assist) Bypass1 recall615 reports
- HVAD® Pump Implant Kit MCS1705PUHeartware Inc. · Ventricular (Assist) Bypass7 recalls36 deaths203 reports
- HVAD® Controller 1403USHeartware Inc. · Ventricular (Assist) Bypass548 reports
- HeartMate™ 107754Thoratec Corporation · Ventricular (assist) bypass2 recalls447 reports
- HeartWare® Battery 1650DEHeartware Inc. · Ventricular (Assist) Bypass1 recall487 reports
- HeartWare® Waist Pack 2050USHeartware Inc. · Ventricular (Assisst) Bypass2 recalls435 reports
- HEARTMATE® POWER MODULE (NA) 1340Thoratec Corporation · Ventricular (Assisst) Bypass1 death402 reports
- HVAD® Controller 1420Heartware Inc. · Ventricular (Assist) Bypass1 recall281 reports
- EXCOR® P15P-001Berlin Heart GmbH · Ventricular (Assisst) Bypass1 recall2 deaths236 reports
- THORATEC® HEARTMATE®, SYSTEM MONITOR 1286Thoratec Corporation · Ventricular (Assisst) Bypass1 recall230 reports
- HEARTMATE®, 14V LI-ION RECHARGEABLE BATTERY SET 2465Thoratec Corporation · Ventricular (Assisst) Bypass259 reports
- HeartMate 3™ 106524USThoratec Corporation · Ventricular (assist) bypass1 recall123 deaths207 reports
- THORATEC® HEARTMATE®, SYSTEM MONITOR 1286A-USThoratec Corporation · Ventricular (Assisst) Bypass1 recall185 reports
- HeartWare® Shoulder Pack 2060USHeartware Inc. · Ventricular (Assisst) Bypass2 recalls117 reports
- HeartWare® Battery 1650DEHeartware Inc. · Ventricular (Assist) Bypass1 recall159 reports
- Patient Pack 1475Heartware Inc. · Ventricular (Assisst) Bypass206 reports
- EXCOR® P10P-001Berlin Heart GmbH · Ventricular (Assisst) Bypass2 recalls1 death103 reports
- HVAD® Pump Implant Kit MCS1705PUHeartware Inc. · Ventricular (Assist) Bypass4 recalls1 report
- HeartWare® Battery 1650DEHeartware Inc. · Ventricular (Assist) Bypass1 recall150 reports
- EXCOR® P30P-001x01Berlin Heart GmbH · Ventricular (Assisst) Bypass2 recalls88 reports
- THORATEC® HEARTMATE II®, LVAS IMPLANT KIT, US, EP 103695Thoratec Corporation · Ventricular (Assisst) Bypass1 recall61 deaths131 reports
- HeartWare® Battery 1650DEHeartware Inc. · Ventricular (Assisst) Bypass1 recall130 reports
- HeartMate 3™ 106531USThoratec Corporation · Ventricular (assist) bypass2 recalls72 reports
- HeartWare® Controller AC Adapter 1430USHeartware Inc. · Ventricular (Assisst) Bypass3 recalls10 reports
- HeartWare® Battery 1650DEHeartware Inc. · Ventricular (Assist) Bypass1 recall109 reports
- EXCOR® P25P-001x01Berlin Heart GmbH · Ventricular (Assisst) Bypass1 recall1 death92 reports
- Thoratec® HeartMate 3™ 105581USThoratec Corporation · Ventricular (Assisst) Bypass2 recalls3 deaths38 reports
- THORATEC® HEARTMATE® XVE AND HEARTMATE II®, APICAL CORING KNIFE 1050Thoratec Corporation · Ventricular (Assisst) Bypass1 recall76 reports
- Patient Pack 1475Heartware Inc. · Ventricular (Assist) Bypass2 recalls18 reports
- THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP 103696Thoratec Corporation · Ventricular (Assisst) Bypass7 deaths111 reports
- HeartWare® Battery 1650DEHeartware Inc. · Ventricular (Assist) Bypass109 reports
- HVAD® Pump Outflow Graft 1125Heartware Inc. · Ventricular (Assisst) Bypass1 recall5 deaths58 reports
- HVAD® Pump Implant Accessories 1153Heartware Inc. · Ventricular (Assisst) Bypass2 recalls2 reports
- Data Cable 1575Heartware Inc. · Ventricular (Assist) Bypass2 recalls0 reports
- HeartMate Touch™ HMT1100Thoratec Corporation · Ventricular (assist) bypass1 recall50 reports
- HeartWare® Controller AC Adapter 1425USHeartware Inc. · Ventricular (Assisst) Bypass1 recall36 reports
- HeartWare® Controller AC Adapter 1430USHeartware Inc. · Ventricular (Assisst) Bypass1 recall25 reports
- THORATEC® HEARTMATE® GOGEAR®, SHOWER BAG 104232Thoratec Corporation · Ventricular (Assisst) Bypass74 reports
- HeartWare® Controller DC Adapter 1435Heartware Inc. · Ventricular (Assisst) Bypass1 recall21 reports
- HeartWare® Controller DC Adapter 1440Heartware Inc. · Ventricular (Assisst) Bypass1 recall19 reports
- EXCOR® P50P-001Berlin Heart GmbH · Ventricular (Assisst) Bypass1 recall2 deaths19 reports
- HEARTMATE® 1440Thoratec Corporation · Ventricular (Assisst) Bypass1 death67 reports
- HEARTMATE®, POWER MODULE PATIENT CABLE 14V 103426Thoratec Corporation · Ventricular (Assisst) Bypass63 reports
- Thoratec® HeartMate 3™ 106531LF2Thoratec Corporation · Ventricular (assist) bypass1 recall12 reports
- HeartWare® Controller DC Adapter 1440Heartware Inc. · Ventricular (Assisst) Bypass1 recall8 reports
- Driveline Extension Cable 100USHeartware Inc. · Ventricular (Assisst) Bypass1 recall6 reports
- EXCOR® P60P-001Berlin Heart GmbH · Ventricular (Assisst) Bypass1 recall6 reports
- HeartMate™ 107760Thoratec Corporation · Ventricular (assist) bypass1 recall6 reports
- HeartMate Touch™ HMT1100-RThoratec Corporation · Ventricular (assist) bypass1 recall3 reports
- HeartWare® Monitor 1521USHeartware Inc. · Ventricular (Assist) Bypass1 recall2 reports
- HVAD® Pump Outflow Graft MCS1725OGHeartware Inc. · Ventricular (Assist) Bypass1 recall1 report
- HVAD® Pump Outflow Graft 1125Heartware Inc. · Ventricular (Assist) Bypass1 recall1 report
- THORATEC® HEARTMATE II®, SEALED OUTFLOW GRAFT WITH BEND RELIEF 103393Thoratec Corporation · Ventricular (Assisst) Bypass1 recall0 reports
- HVAD® Pump Implant Accessories MCS1753AKHeartware Inc. · Ventricular (Assist) Bypass1 recall0 reports
- HeartMate 3™ 106531LF2Thoratec Corporation · Ventricular (assist) bypass1 recall0 reports
- HeartMate™ 106128Thoratec Corporation · Ventricular (assist) bypass1 recall0 reports
- HeartMate® Sealed Lead Acid Battery 109200Thoratec Corporation · Ventricular (Assisst) Bypass46 reports
- HEARTMATE®, 14V LI-ION BATTERY CLIP SET 2865Thoratec Corporation · Ventricular (Assisst) Bypass45 reports
- THORATEC® HEARTMATE®, 11 VOLT LI-ION BACKUP BATTERY 106128Thoratec Corporation · Ventricular (Assisst) Bypass42 reports
- HeartWare® Shower Bag 2000USHeartware Inc. · Ventricular (Assisst) Bypass32 reports
- HeartMate II®, System Controller 10005080Thoratec Corporation · Ventricular (Assisst) Bypass24 reports
- HeartWare® Battery Charger 1600USHeartware Inc. · Ventricular (Assisst) Bypass23 reports
- Thoratec® HeartMate 3™ 10005877Thoratec Corporation · Ventricular (assist) bypass22 reports
- HeartWare® Controller AC Adapter 1430USHeartware Inc. · Ventricular (Assist) Bypass20 reports
- HEARTMATE MOBILE POWER UNIT, CA 107754OUSThoratec Corporation · Ventricular (Assisst) Bypass18 reports
- EXCOR® L20H-002x01Berlin Heart GmbH · Ventricular (Assisst) Bypass15 reports
- EXCOR® D03I-111Berlin Heart GmbH · Ventricular (Assisst) Bypass14 reports
- HeartMate 3™ 106525USThoratec Corporation · Ventricular (assist) bypass13 reports
- THORATEC® PVAD™, VENTRICULAR ASSIST DEVICE - BLOOD PUMP 14086-2550-000Thoratec Corporation · Ventricular (Assisst) Bypass6 deaths11 reports
- EXCOR® A06-009Berlin Heart GmbH · Ventricular (Assisst) Bypass11 reports
- EXCOR® C80G-021mBerlin Heart GmbH · Ventricular (Assisst) Bypass1 death11 reports
- Thoratec® HeartMate 3™ 10005872Thoratec Corporation · Ventricular (assist) bypass10 reports
- HeartWare® Battery 1650Heartware Inc. · Ventricular (Assisst) Bypass10 reports
- HeartMate Touch™ HMT2100Thoratec Corporation · Ventricular (assist) bypass10 reports
- EXCOR® C18A-020Berlin Heart GmbH · Ventricular (Assisst) Bypass9 reports
- HVAD® Pump Surgical Tools 1318Heartware Inc. · Ventricular (Assisst) Bypass8 reports
- HeartWare® Controller DC Adapter 1440Heartware Inc. · Ventricular (Assist) Bypass7 reports
- EXCOR® C22A-004Berlin Heart GmbH · Ventricular (Assisst) Bypass2 deaths7 reports
- Thoratec® HeartMate 3™ 106522USThoratec Corporation · Ventricular (assist) bypass7 reports
- HeartWare® Controller AC Adapter 1430USHeartware Inc. · Ventricular (Assist) Bypass6 reports
- HeartMate™ GoGear™ 104232Thoratec Corporation · Ventricular (assist) bypass6 reports
- HEARTMATE®, SYSTEM MONITOR TO POWER MODULE CABLE 103859Thoratec Corporation · Ventricular (Assisst) Bypass5 reports
- EXCOR® A09-009Berlin Heart GmbH · Ventricular (Assisst) Bypass5 reports