More News about the HeartMate II and HeartMate 3 Recalls
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April 21, 2024
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KBA Attorneys
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Our firm handles medical device cases. These can be complex, difficult cases because of legal issues like medical device preemption. One type of medical device is heart pumps and related devices.
Heart Device Failures
Our firm investigates heart pump and other heart-related medical device failures. We have written about heart pump failures recently – twice in April. The Impella heart pump failed. The manufacturer recalled it as FDA announced in April.
Before the Impella Heart Pump recall, FDA announced a recall of the HeartMate II and HeartMate 3 Left Ventricular Assist Systems. The FDA set forth a Class 1 Device Recall HeartMate II Left Ventricular Assist System. There is also an FDA Class 1 Device Recall for the HeartMate 3 Left Ventricular Assist System. These are the most serious recalls within the FDA world.
Reason for the HeartMate Recalls
FDA’s recall notice explained that the HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) presents risks associated with “Extrinsic Outflow Graft Obstruction.” FDA explained that “This happens when biological material builds up between the HeartMate Outflow Graft and the Outflow Graft Bend relief or additional components added during surgery.” The problem is that “This buildup can obstruct the device, making it less effective in helping the heart pump blood.” That may “trigger alarms indicating low blood flow and affect the device’s ability to help the heart properly. The accumulation of biological material typically occurs over two years or more.”
This is a big deal because “The use of affected LVAS may cause serious adverse health consequences and in worst cases, could result in death.”
Full List of Affected HeartMate Devices
The following Model Numbers are those of concern per FDA’s recall notice:
| Device | UDI-ID | Firm Reference Number |
|---|---|---|
| HeartMate II Sealed Outflow Graft with Bend Relief | 00813024010807 | 103393 |
| HeartMate II LVAS Implant Kit | 00813024011224 | 106015 |
| HeartMate II LVAS Implant Kit (Unsealed Outflow Graft with Bend Relief) | 00813024010005 | 1355 |
| HeartMate II LVAS Implant Kit (with RSOC Controller) | 00813024010616 | 103695 |
| HeartMate II LVAS Implant Kit (with Sealed Graft) | 00813024011170 | 104911 |
| HeartMate II LVAS Implant Kit (Used for pump exchange, No Graft) | 00813024011996 | 107801 |
| HeartMate 3 Sealed Outflow Graft with Bend Relief | 00813024013266 | 105581US |
| HeartMate 3 LVAS Implant Kit | 00813024013297 | 106524US |
American News Reports Provide New Details
US News reports that ” About 14,000 of the devices are thought to be under recall, but as of now the two devices are not being removed from the market.” This article also revealed that “One study published in 2022 in the Journal of Thoracic and Cardiovascular Surgery found the blockages occurred in about 3% of patients with the devices, with the likelihood of obstructions rising over time.” The Chicago Sun Times reported further that the recall arises from 14 deaths.
CBS News’ reporting on this topic notes the hidden risks at issue: “Why doesn’t the public know?” said Sanket Dhruva, a cardiologist and an expert in medical device safety and regulation at the University of California-San Francisco. Though some surgeons may have been aware of issues, others, particularly those who do not implant the device frequently, may have been in the dark. “And their patients are suffering adverse events,” he said.
If You or A Loved Suffered After Use of a the Impella Heart Pump or a HeartMate Device, please Contact Us today.
