Abiomed is recalling the instructions for use (IFU) for its Impella left-sided blood pumps due to the risk of serious health consequences. The US FDA has classified this as a Class I recall, with 129 reported serious injuries and 49 deaths. The affected devices include Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD.
Abiomed is recalling the instructions for use (IFU) for its Impella left-sided blood pumps due to the risk of the pump catheter perforating the wall of the left ventricle. The US FDA has classified this as a Class I recall, the most serious type, as it may cause serious adverse health consequences, including left ventricle perforation or free wall rupture . There have been 129 reported serious injuries, including 49 deaths. The affected devices include Impella 2.
5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD
Abiomed Impella Blood Pumps Recall Instructions For Use Left Ventricle Perforation Free Wall Rupture FDA Class I Recall Serious Injuries Deaths
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Another Class I Recall for Abiomed Impella Left-Sided Blood PumpsAbiomed says the pump catheter may perforate the wall of the left ventricle. Instructions for use have been updated to address the issue.
Read more »
U.S. Integrity Reportedly Flags College Basketball Game for Unusual BettingOne-sided line movement in UAB-Temple matchup catches the eye of sports betting monitoring company.
Read more »
D.C. condos near Rock Creek Park and MetroBuying new | Five-sided building provides varied floorplans
Read more »
After Five Years, the Patrick Mahomes Trade Is Officially ResolvedThink the Patrick Mahomes trade was one-sided? Well, a final personnel transaction has finally closed the book.
Read more »
Joshua takes out Ngannou with crushing KO finish in Round 2In a one-sided destruction, Anthony Joshua dropped Francis Ngannou three times Friday night, ending their bout with a perfectly placed right hand in Round 2.
Read more »
Supreme Court rules unanimously for Trump in Colorado ballot disqualification disputeThe Supreme Court sided with former President Donald Trump in his challenge to the state of Colorado’s attempt to kick him off the 2024 primary ballot.
Read more »