Medtronic Issues Recall for HVAD Pump Outflow Graft

Medtronic is recalling its HeartWare HVAD pump outflow graft and outflow graft strain relief because of the risk of breaks and tears during the pre-implant pump assembly process. FDA has identified this as a Class I recall. The Dublin-based company said it has received 92 complaints. The recalled products according to FDA’s release are: HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Model Numbers:HVAD Pump Outflow Graft: 1125 HVAD Pump Implant Kit: 1103 HVAD Implant Accessories Kit: 1153 Distribution Dates: March 1, 2018 to April 1, 2020   Medtronic said the use of the affected products may cause serious patient harm including dizziness, loss of consciousness, bleeding, fluid buildup around the heart, additional medical procedures, and death. The HVAD System is used as a bridge to cardiac transplants in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients where new transplants are not planned. The company inherited the HVAD technology when it acquired HeartWare International for $1.1 billion. The deal put Medtronic on more even footing with St. Jude Medical, which acquired HeartWare’s rival Thoratec, for $3.3 billion in 2015. (Editor’s Note: Abbott Laboratories would go on to acquire St. Jude Medical for $25 billion in 2017.) This isn’t the first time there have been issues or ...
Source: MDDI - Category: Medical Devices Tags: Cardiovascular Regulatory and Compliance Source Type: news