Almost 14,000 Assistive Heart Devices Have Been Recalled Nationwide

The Food and Drug Administration (FDA) has announced a Class I recall for thousands of devices that assist the heart in pumping, citing reports of several deaths and multiple injuries. The recall affects 13,883 HeartMate II and HeartMate 3 Left Ventricular Assist System devices distributed by Abbott/Thoratec Corp. 

Either of these two lifesaving devices may be used when there is a malfunction in the left ventricle, the heart’s pumping chamber. Both models are designed to redirect blood flow to the aorta, facilitating circulation throughout the body, aiding in the heart’s recovery or providing long-term support. While HeartMate II is exclusively for adult patients, HeartMate 3 can also be used in pediatric cases.

The recall was issued because the HeartMate devices, distributed since April 21, 2008, may accumulate biological material that obstructs their function, resulting in decreased efficiency in blood circulation. Over time, this accumulation can worsen, potentially causing devices to malfunction leading to severe injuries or fatalities.

This issue, known as Extrinsic Outflow Graft Obstruction (EOGO), may not manifest for several years, with the damaging buildup taking two years or more to cause noticeable issues. The buildup can trigger low-blood flow alarms in the device. To date, 14 deaths and 273 injuries have been reported in connection with these devices.

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Patients and healthcare providers using these devices should have received an “Urgent Medical Device Correction Letter” from Thoratec Corporation sent on February 19, 2024. The FDA’s announcement states that all recipients should return the acknowledgment form enclosed with the letter and be on alert for additional communications until corrective measures are implemented. It’s said the letter also encouraged patients and caregivers to “pay attention to low flow alarms as this is the first symptom of significant outflow obstruction.” It included additional guidance for healthcare providers on diagnosing low-flow issues. 

For inquiries about the recall, individuals should contact Abbott/Thoratec Corporation at (844) 692-6367.

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The full list of affected devices:

• HeartMate II Sealed Outflow Graft with Bend Relief  
  • UDI-ID: 00813024010807
  • Firm Reference Number: 103393

• HeartMate II LVAS Implant Kit
  • UDI-ID: 00813024011224
  • Firm Reference Number: 106015

• HeartMate II LVAS Implant Kit (Unsealed Outflow Graft with Bend Relief)
  • UDI-ID: 00813024010005
  • Firm Reference Number: 1355

• HeartMate II LVAS Implant Kit (with RSOC Controller)
  • UDI-ID: 00813024010616
  • Firm Reference Number: 103695

• HeartMate II LVAS Implant Kit (with Sealed Graft)
  • UDI-ID: 00813024011170
  • Firm Reference Number: 104911

• HeartMate II LVAS Implant Kit (Used for pump exchange, No Graft)
  • UDI-ID: 00813024011996
  • 107801

• HeartMate 3 Sealed Outflow Graft with Bend Relief
  • UDI-ID: 00813024013266
  • 105581US

• HeartMate 3 LVAS Implant Kit
  • UDI-ID: 00813024013297
  • 106524US

The FDA emphasizes that this recall serves to alert users to a crucial correction rather than remove the product from the market.

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