The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-2193-2021·Announced 2021-08-18

HeartWare HVAD Driveline Extension Cable Recalled for Cardiac Safety Concerns

Medtronic is recalling the HeartWare HVAD Driveline Extension Cable (443 units) due to higher frequency of neurological adverse events and mortality in clinical comparisons with other heart assist devices. The pump may experience restart delays or failures.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I classification is designated as critical in the severity rubric. The source also explicitly documents mortality associated with the HeartWare HVAD system, along with a higher frequency of neurological adverse events compared to other devices.

Plain-English summary

Medtronic is recalling the HeartWare HVAD Driveline Extension Cable, REF 100US, worldwide. This device is a component of the HeartWare HVAD System, a left ventricular assist device used to support heart function in patients with advanced heart disease. The recall affects 443 units distributed across the United States and internationally.

The recall is based on a growing body of observational clinical comparisons showing that the HeartWare HVAD system is associated with a higher frequency of neurological adverse events and mortality when compared to other commercially available left ventricular assist devices. Additionally, Medtronic has received complaints that the internal pump may experience restart delays or complete failure.

The FDA has classified this as a Class I recall, indicating a serious safety concern. Patients and healthcare providers using this device should contact their medical team immediately to discuss their individual situations and available alternatives. Medtronic has ceased distribution and sale of the HVAD System.

The recalled product

Product
HeartWare HVAD Driveline Extension Cable, REF 100US
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiac assist device
Hazard
Affected units
443

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • GTIN: 00888707000024 All serial numbers

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Heartware, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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