Company: Medtronic
Date of Enforcement Report: 3/1/2021
Class I
PRODUCT
HVAD Pump Implant Kits for the HeartWare HVAD System
- PUMP 1103
- PUMP 1104
- PUMP 1104JP
The HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit is part of the HeartWare HVAD System, which is used to help the heart continue to pump blood to the rest of the body. 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.
Recall Number: Z-0946-2021
REASON
Medtronic is recalling the HVAD Pump Implant Kit because the device may fail to initially start, restart, or have a delay in restarting after the pump was stopped. These delays or failures to start or restart have occurred during preimplant testing, during the implant, or in a variety of post-implant situations. If the device has delays or fails to start or restart, this could cause serious patient harm including a heart attack, worsening heart failure, the need for additional procedures and hospitalizations, or death.
There have been 29 complaints about this device issue, which include 19 serious injuries and 8 cases of patients who had a life-threatening event but recovered without long term effects. Two deaths have been reported.
RECALLING FIRM/MANUFACTURER
Medtronic on 12/7/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
386 units
DISTRIBUTION
U.S. Nationwide and International