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 recalls related to the HVAD technology. About two years ago, the company had a recall that included 204,017 of its devices. The issue stemmed from an interruption of the electrical connection between the device’s power source and the HVAD controller.
There were two significant recalls involving the HVAD just before after Medtronic acquired HeartWare in 2016.
One involved 8,799 HVAD controllers that were potentially damaged from exposure to moisture through loose power and data connectors. The other involved 350 unimplanted kits sitting in hospital inventory that were susceptible to electrical faults and connection failures from fluid entering the driveline-to-controller connector.
HeartWare had a major battery recall involving more than 18,000 HVAD batteries sold between 2013 and 2015, also prior to Medtronic buying the company.