Abiomed Impella Recall Issued For Heart Pump Catheter’s Instructions Due to Blood Clot Risks
The third Impella heart pump recall in as many months warns that they lack instructions for doctors on the risks of blood clots linked to the devices.
Tag Archives: Heart Pump
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Impella Left Sided Blood Pump Recall Issued Due to Risk Contact with TAVR Stents May Cause Motor Damage
The FDA warns about 8,000 Abiomed Impella blood pumps may suffer motor damage when placed too close to TAVR valves, leading to an increased risk of severe injury and death.
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Impella 5.5 Heart Pump Recall Follows Reports of Fluid Leaks and Patient Injuries
Nearly 500 Impella 5.5 heart pumps by Abiomed have been recalled following reports of fluid leaks, pump failures and patient injuries.
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New Clinical Data Shows Abiomed Impella RP Heart Pump is Safe, Despite Concerns Over Patient Deaths: FDA
The FDA has released clinical trial data on Abiomed Impella RP Heart Pump Systems, declaring the device safe, but updated its warning label to recommend it only be used on…
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HeartWare Heart Pump Problems Were Known, But Dangerous Implants Continued: Report
A new report indicates the FDA and Medtronic knew of HeartWare implant problems and deaths for years, but took little action to make the devices safer and kept allowing them…
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Abiomed Impella RP Heart Pump Side Effects May Include High Rate Of Patient Deaths, FDA Warns
The FDA warns that a heart pump used for emergency procedures has a high rate of death among some types of patients.
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Abiomed AB5000 Circulatory Support System Recall: Risk of Injury or Death
A Class 1 medical device recall has been issued for Abiomed, Inc.’s AB5000 Circulatory Support System after it was determined that the device, which keeps the heart pumping in cases…
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Thoratec HeartMate II Blood Pump Warning: Lead May Fail
Thoratec Corporation has warned that their HeartMate II blood pump may fail due to a defective lead that connects the heart pump with the System Controller. The lead has been…
