Dive Brief:
- Another recall regarding Medtronic's HeartWare HVAD system was labeled a Class I event by the FDA on Wednesday, marking the system's third Class I recall of 2021 and fifth since 2018.
- The most recent recall is regarding instructions for use and patient manuals covering three aspects of the HeartWare HVAD system: HVAD carrying cases, the driveline covering orientation and the controller power-up sequence. The recall affects numerous HVAD models and product components. One death and 64 injuries have been reported due to the issues outlined by the FDA.
- A Medtronic spokesperson said in an emailed statement that customers were notified of the issues in February and the company is currently updating patient manuals and instructions for use. The recall is just related to the instructions and manuals; no items such as HVAD systems or components to systems are being impacted, according to the company.
Dive Insight:
Medtronic's HeartWare HVAD system, which helps the heart continue to pump blood to the rest of the body, has been plagued with issues all year. In March, the system had a Class I recall due to failed or delayed restarts after pumps are stopped. The malfunction resulted in 29 complaints, including reports of 19 serious injuries and two patient deaths.
In April, a list of HeartWare HVAD parts — battery, data and adapter cables and controller 2.0 ports — were part of a Class I recall. The FDA said that 12 deaths and eight injuries were reported due to the issues.
Medtronic gave a different accounting of the deaths involved in an emailed statement at the time of the recall notice, suggesting one was related to the issue, seven were potentially related and three, they contend, were not related, as of Jan. 7.
The HeartWare HVAD system also had one Class I recall in both 2020 and 2018.
Michael Argentieri, vice president at patient safety organization ECRI, said in an emailed statement last month that the group has issued 39 alerts about safety risks with Medtronic's HeartWare product line since 2010.
The most recent recall is for patient manuals and instructions for use for several components of the HeartWare HVAD System.
The first update will be for the carrying case of the device. A drop of the carrying case, which can come from damage to the case or improper wear, can cause the driveline to be disconnected and disrupt the power supply to the pump. Medtronic is updating manuals and instructions about the lifespan of the cases, and how to safely clean and wear the Convertible Patient Pack, according to the notice.
Another issue is regarding the power-up sequence of the pump. A red light that appears when the pump is powering up can be misinterpreted as a "red alarm" battery failure. A third issue outlined in the notice is regarding the driveline cover, which can be put on backwards when patients replace drivelines and result in the disconnection of the part.
All of these issues can result in serious patient harm, including deaths, according to the FDA.
Medtronic said in the statement that patient manuals and instructions for use will be updated for the HVAD System carrying cases useful life, HVAD Controller power-up sequence, expected HVAD System alarm duration and the HVAD Controller connections audible alert.
Updates for the HVAD System carrying case care and the HVAD System driveline cover instructions will be made to patient manuals only.
"We recommend that customers review the updated Instructions for Use and Patient Manual, share with patients as needed, and share with all those who need to be aware within the organization or to another organization where potentially affected patients have been transferred," the company said in a statement.
