THORATEC® HEARTMATE II®, SEALED OUTFLOW GRAFT WITH BEND RELIEF 103393Recalls & reported problems
Thoratec Corporation · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Feb 19, 2024Class IOpen, Classified
Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
Z-1300-2024 · Root cause: Material/Component Contamination · Recall details · FDA record ↗
Other Ventricular (Assisst) Bypass devices
- 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
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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