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: Abiomed
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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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Abiomed Impella RP System Linked To Increased Risk Of Patient Deaths, FDA Warns
The FDA warns that the Abiomed Impella RP System has a higher rate of mortality among patients than its initial clinical trials predicted, potentially because the manufacturer did not take…
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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…
