Topic Archives: Impella Heart Pump
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Impella CP Heart Pump Recall Issued For Devices Shipped After Failing Inspections
AbioMed has issued several Impella Heart Pump recalls in recent years over the potential for the devices to cause heart wall tears and life-threatening bleeding events, among other injuries.
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Thoratec HeartMate System Monitor Recall Issued Due Screen Problems That May Lead to Brain Damage, Strokes, Death
Screen problems with Thoratec HeartMate systems have been linked to dozens of patient injuries, in the latest recall impacting the product.
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Study Finds Balloon-Expandable Valves Used After TAVR Procedures Linked to Valve Dysfunction and Mortality Risks
Researchers warn that individuals who received balloon-expandable valves were more than four times more likely to suffer valve dysfunction that could lead to blood leaks or valve failure.
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Abbott Heartmate 3 Recall Issued After Reports of Blood Leaks, Air Embolism and Heart Failures
Manufacturer indicates that healthcare professionals should keep an alternative left ventricle assist device (LVAD) on standby in the event of a Heartmate 3 failure.
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Study Links Impella Heart Pump to Severe Bleeding, Limb Damage and Other Serious Complications
Cardiology experts have linked the Impella heart pump to a four-fold risk of worsening heart conditions and kidney problems.
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HeartMate II and HeartMate 3 LVAS Recall Follows 14 Deaths, Hundreds of Injuries
The FDA has announced yet another recall for HeartMate left ventricle assist systems, which have been linked to serious problems in recent years, and may have contributed to dozens of patient deaths.
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Impella Pump Heart Perforation Problems Were Not Adequately Disclosed to FDA: Report
FDA recently warned about a serious risk of heart perforations from Impella pumps, due to faulty instructions that may have resulted in more than 100 injuries and nearly 50 deaths
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Impella Left Sided Blood Pump Recall Issued Over Risk of Perforations Due to Faulty Instructions
FDA indicates that a recent update to the instructions constitutes a Class I recall, since problems with the Impella Blood Pumps can lead to severe injury or death
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Abiomed Impella Recall Issued For Heart Pump Catheter’s Instructions Due to Blood Clot Risks
This is the third Impella heart pump recall issued in recent months, following reports of injuries and deaths due to device failures.
