The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

• HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports
• Product Numbers:
  • Medtronic HVAD Controller AC Adapter: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US
  • Medtronic HVAD Controller DC Adapter: 1440
  • Battery: 1650DE
  • Alarm Adapter: 1450
  • Monitor Data Cable: 1575
  • Controller: 1400, 1401, 1403, 1407, 1420
• Manufacturing Dates: March 7, 2006 to present
• Distribution Dates: October 9, 2006 to present
• Devices Recalled in the U.S.: 106,366
• Date Initiated by Firm: February 26, 2021

Device Use

The HeartWare Ventricular Assist Device (HVAD) Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports are part of the HeartWare HVAD System, which is used to help the heart continue to pump blood to the rest of the body (See Figure 1). 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.

Figure 1: The HeartWare HVAD System, showing the HVAD controller and power sources which are part of the recall

Reason for Recall 

Medtronic is recalling the HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports because of risk of wear and tear of the connector plugs (power sources, data cable, and alarm adapter) which could cause damage to the Controller port metal pins (for example, bent pins).

Damaged controller ports may prevent power cables and data cables from being connected to the controller and lead to a full or partial stop of the pump. This could cause serious patient harm including loss of consciousness, hospitalization, heart attack, or death.
 
There have been 12 deaths and 8 injuries reported to the FDA.

Who May be Affected

• Health care providers using the affected Medtronic device
• Patients who have procedures with the affected Medtronic device

What to Do

On February 26, 2021, Medtronic sent an Urgent Medical Device Notice to all affected customers. The notice instructed customers to:

• Review the content in Appendix A of the Urgent Medical Device Notice that provides additional instructions on the frequency of inspecting the HVADTM Controller, HVADTM Controller power cables (AC Adapter, DC Adapter, and Battery cables), and HVADTM Monitor data cables
• Review the content in Appendix A of the Urgent Medical Device Notice with your patients who are currently on support
• Share the notice with all those who need to be aware within organizations or to any organization where potentially affected patients have been transferred
• Complete a Customer Confirmation Form (enclosed with the Urgent Medical Device Notice) and return via email to [email protected]

Appendix A - Patient Management Recommendations

Medtronic is making the following recommendations to prevent damage to connector pins:

• Inspect the following HeartWare HVAD System components during clinic visits: Controller AC and DC Adapters, Batteries and Alarm Adapter for wear and damage
  • Damage and wear include but are not limited to:
    • Connector plugs: scratches on plug face, surface irregularity, dents, chips or cracks
    • Cables: dents, chips, or cracks
• Take out of service damaged or worn AC Adapters, DC Adapters, Batteries and Alarm Adapters and replace with new components.
  • Damaged equipment should be reported to your clinician and replaced.

Medtronic also wants to reinforce the following section from the existing Instructions for Use (IFU) and Patient Manual (PM):

• Instruct patients to carefully follow the guidance provided in the patient manual related to Controller Care and Battery Care.
  • Pay attention when connecting and disconnecting power supply cables to ensure connections are not forced together without proper alignment.
  • Once a week:
    • Inspect the power connectors and connector pins on the controller for dirt or grime.
      • This inspection can be done during changing of power sources
      • Check the controller power connectors one at a time
        • DO NOT disconnect both power source at the same time or the pump will stop
        • DO NOT disconnect the driveline to examine its connector
          • The only time the driveline connector should be inspected in during a controller exchange
        • DO NOT attempt to clean the controller connectors
          • Report the condition to your clinician if any dirt is found
    • Inspect batteries for physical damage, including the battery cable and connections
      • DO NOT use batteries that appear damaged
        •  Damaged batteries must be replaced
• Reinforce existing Instructions for Use and Patient Manual Cautions and Warnings associated with the connections:
  • CAUTION: When connecting cables, DO NOT force connectors together without proper alignment. Forcing together misaligned connectors may damage the connectors.
  • CAUTION: ALWAYS confirm that the power cables are properly locked on the controller by gently pulling the cable near the controller power connector or the power cables may come loose and result in an alarm or the pump stopping.
  • CAUTION: ALWAYS keep all connectors free of liquid, dust and dirt, or the HeartWare HVAD System may not function as intended.
  • WARNING! DO NOT drop the controller or other equipment. Dropping the controller could cause sudden stoppage of the pump. Dropped equipment should be reported to HeartWare and inspected.
  • CAUTION: DO NOT attempt to repair or service any components of the HeartWare System. If HeartWare® System equipment malfunctions, contact HeartWare.

Contact Information

Customers who need additional information about this recall can contact Medtronic Mechanical Circulatory Support Customer Service by phone at 877-367-4823.

Additional Resources:

• Medical Device Recall Database Entry

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.