A high-priority new recall has been issued for Medtronic HVAD Pump Implant Kits. These kits are utilized in sufferers affected by extreme coronary heart illness, particularly these in want of a transplant however who haven’t but discovered a donor. When this challenge happens, the pumps won’t be able to restart as soon as stopped or will expertise a delay in restarting. Delays and failed reactivations may end up in additional coronary heart harm and even dying. To date, there have been 19 severe incidents and a couple of deaths attributed to the gear.
The FDA’s recall discover and directions for healthcare professionals and sufferers affected are included beneath.
The FDA has recognized this as a Class I recall, probably the most severe sort of recall. Use of those gadgets might trigger severe accidents or dying.
- HVAD Pump Implant Kits for the HeartWare HVAD System
- Mannequin: Medtronic HVAD Pump Implant Kits, labeled as:
- PUMP 1103
- PUMP 1104
- PUMP 1104JP
- Distribution Dates: October 23, 2017 to April 30, 2020
- Units Recalled within the U.S.: 157
- Date Initiated by Agency: November 19, 2020
The HeartWare Ventricular Help Machine (HVAD) Pump Implant Package is a part of the HeartWare HVAD System, which is used to assist the center proceed to pump blood to the remainder of the physique. The HVAD system is used as a bridge to cardiac transplants in sufferers who’re susceptible to dying from end-stage left ventricular coronary heart failure, for coronary heart tissue restoration, or as vacation spot remedy (DT) in sufferers the place new transplants aren’t deliberate.
Purpose for Recall
Medtronic is recalling the HVAD Pump Implant Package as a result of the system might fail to initially begin, restart, or have a delay in restarting after the pump was stopped. These delays or failures to begin or restart have occurred throughout preimplant testing, in the course of the implant, or in a wide range of post-implant conditions. If the system has delays or fails to begin or restart, this might trigger severe affected person hurt together with a coronary heart assault, worsening coronary heart failure, the necessity for added procedures and hospitalizations, or dying.
There have been 29 complaints about this system challenge, which embrace 19 severe accidents and eight instances of sufferers who had a life-threatening occasion however recovered with out long run results. Two deaths have been reported.
Who Could also be Affected
- Well being care suppliers utilizing the affected HVAD Pump Implant Kits
- Sufferers who’ve procedures with the affected system
What to Do
On December 18, 2020, Medtronic despatched an Pressing Medical Machine Communication Letter to all affected clients and on December 23, 2020, Medtronic despatched an Pressing Medical Machine Communication Letter to all accounts who’ve beforehand bought a Medtronic HVAD Pump. The discover instructed clients to:
- Advise well being care suppliers and workers the next factors from the present Directions for Use (IFU) to keep away from pointless pump stops:
- Don’t disconnect the driveline from the controller.
- Don’t disconnect each energy sources (batteries and AC or DC adapter) from the controller on the similar time; one exterior energy supply ought to all the time stay related to the controller.
- Don’t change the controller except explicitly directed by a Excessive Precedence alarm situation or by a VAD workforce member.
- Reinforce the right response to a [Controller Fault] alarm and [Electrical Fault] alarm. These are Medium Precedence alarms unrelated to a right away pump cease. These alarms will outcome within the phrase [Call] within the Controller Show, notifying the affected person to name their clinician.
- Reinforce making good connections of energy sources and the info cable within the controller ports.
- Inform sufferers implanted with considered one of these recognized pumps to contact their Ventricular Help Machine coordinator previous to any controller change, and to coordinate performing an change of controllers in a scientific setting.
- Determine if a controller change is deemed vital for sufferers implanted with considered one of these recognized pumps and think about the next:
- Controller exchanges must be carried out beneath clinician supervision in a managed setting with instant capacity to place the affected person on hemodynamic help. Failure to restart may be deadly.
- Upon a pump cease, a Excessive Precedence [VAD Stopped] alarm will outcome within the phrases [Change Controller] or [Connect Driveline] within the Controller Show. As soon as energy and driveline connections are reestablished, if the pump doesn’t restart:
- Contemplate energy biking of the present controller or think about a controller change. This may enable the restart algorithm to reset and begin over. The controller routinely makes an attempt to restart the pump a most of 30 occasions; the [VAD Stopped] alarm begins after 5 (5) makes an attempt.
- If the pump nonetheless doesn’t restart, proceed with short-term hemodynamic help and pump change.
- Schedule a controller change previous to the inner controller battery reaching finish of life and triggering a [Controller Fault] alarm if a affected person’s controller is past two (2) years of service.
- Though a [Controller Fault] alarm is a Medium Precedence alarm that isn’t associated to a pump cease, proactively scheduling a controller change may assist keep away from a affected person reacting to the alarm by exchanging a controller exterior of a scientific setting. Per the IFU, sufferers ought to name their clinician upon receiving a Medium Precedence alarm.
- Assessment serial numbers within the letter and make sure if sufferers are nonetheless on help.
- Share the letter with all those that must be conscious inside organizations or to any group the place doubtlessly affected sufferers have been transferred.
- Full a Doctor Affirmation Kind (enclosed with the letter) and return by way of e-mail to [email protected].
Clients who want extra details about this recall can contact Medtronic Mechanical Circulatory Help Buyer Service by cellphone at 877-367-4823 or mail:
710 Medtronic Pkwy Mailstop Ls245
Minneapolis MN 55432-5603
- Medical Device Recall Database Entry
- Medtronic Urgent Medical Device Communication External Link Disclaimer
How do I report an issue?
Well being care professionals and customers might report adverse reactions or quality problems they skilled utilizing these gadgets to MedWatch: The FDA Security Info and Hostile Occasion Reporting Program utilizing an internet type, common mail, or FAX.