A new high priority recall has been issued for Medtronic HVAD Pump Implant Kits. These kits are used in patients with severe heart disease, especially those who need a transplant but have not yet found a donor. When this problem occurs, the pumps cannot restart after stopping or there is a delay in restarting. Delays and failed reactivations can lead to further heart damage or even death. To date, 19 serious incidents and 2 deaths have been attributed to the equipment.
The FDA recall notice and instructions for healthcare professionals and affected patients are listed below.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices could result in death or serious injury.
- HVAD Pump Implant Kits for the HeartWare HVAD System
- Model: Medtronic HVAD Pump Implant Kits, Tagged As:
- PUMP 1103
- PUMP 1104
- PUMP 1104JP
- Distribution dates: October 23, 2017 to April 30, 2020
- Devices recalled in the US: 157
- Date initiated by the company: November 19, 2020
The HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit is part of the HeartWare HVAD system that allows the heart to continue pumping blood to the rest of the body. The HVAD System is used as a bridge to heart transplants in patients at risk of death from end-stage left ventricular heart failure, to restore heart tissue, or as target therapy (DT) in patients who are not scheduled for new transplants.
Reason for the recall
Medtronic is recalling the HVAD Pump Implant Kit because the device may fail to start, restart, or delayed restarting after the pump stops. These delays or errors in starting or restarting have occurred during pre-implant testing, during the implant, or in a variety of post-implant situations. If the device delays, or fails to start or restart, it could cause serious harm to the patient, including heart attack, worsening heart failure, need for additional procedures and hospitalizations, or death.
There were 29 complaints related to this device issue, including 19 serious injuries and 8 cases from patients who had a life-threatening event but recovered with no long-term effects. Two deaths have been reported.
Who can be affected
- Healthcare providers using the affected HVAD pump implant kits
- Patients who have had surgery with the affected device
What should I do
On December 18, 2020, Medtronic sent an urgent medical device communication letter to all affected customers, and on December 23, 2020, Medtronic sent an urgent medical device communication letter to all accounts that had previously purchased a Medtronic HVAD pump. The notice instructed customers:
- Inform healthcare providers and employees about the following points from the current Instructions for Use (IFU) to avoid unnecessary pump stops:
- Do not disconnect the drive train from the controller.
- Do not disconnect both power sources (batteries and AC or DC adapter) from the controller at the same time. An external power source should always remain connected to the controller.
- Do not replace the controller unless specifically directed by a high priority alarm condition or by a VAD team member.
- Reinforce the correct response to an alarm (Controller Fault) and an alarm (Electrical Fault). These are medium priority alarms that are not related to an immediate pump stop. These alarms result in the word (call) on the controller display prompting the patient to call their doctor.
- Make sure that the power sources and the data cable in the controller ports are well connected.
- Advise patients implanted with any of these identified pumps to contact their ventricular assist device coordinator prior to a controller exchange and to coordinate the performance of a controller exchange in a clinical setting.
- Determine whether regulator replacement is deemed necessary for patients implanted with one of these identified pumps, and consider the following:
- The controller exchange should be performed under the supervision of the clinician in a controlled environment in which the patient can receive immediate hemodynamic support. A failed restart can be serious.
- When the pump stops, a high priority alarm (VAD stopped) results in the words (change controller) or (connect drive train) in the controller display. Once power and driveline connections are restored, if the pump does not restart:
- Take into account switching the current controller off and on or a controller replacement. This allows the restart algorithm to be reset and restarted. The controller automatically tries to restart the pump a maximum of 30 times. The alarm (VAD stopped) will start after five (5) attempts.
- If the pump still does not restart, continue with temporary hemodynamic support and pump replacement.
- Plan to replace the controller before the internal controller battery reaches the end of its life and triggers an alarm (controller failure) if a patient's controller has been in use for more than two (2) years.
- Although an alarm (controller failure) is a medium priority alarm unrelated to a pump stop, proactive planning of a controller replacement can help prevent a patient from responding to the alarm by replacing a controller outside of a clinical setting . According to the IFU, patients should call their doctor if they receive a medium priority alarm.
- Check the serial numbers in the letter and confirm that the patients are still receiving assistance.
- Share the letter with anyone who needs to know within organizations or to organizations where potentially affected patients have been transferred.
- Complete a Physician Confirmation Form (attached to the letter) and email it to [email protected]
Customers with additional information about this recall can call Medtronic Mechanical Circulatory Support by phone at 877-367-4823 or email:
710 Medtronic Pkwy Mailstop Ls245
Minneapolis MN 55432-5603
- Database entry for the recall of medical devices
- Medtronic Urgent Medical Device Communication External Link Disclaimer
How do I report a problem?
Healthcare professionals and consumers can use an online form, mail, or fax to MedWatch: The FDA's Safety Information and Adverse Event Reporting Program, to report any side effects or quality problems experienced with the use of these devices.