The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-2196-2021·Announced 2021-08-18

Heartware HVAD ventricular assist device recalled due to mortality risk

Medtronic recalled the Heartware HVAD Outflow Graft worldwide due to higher rates of neurological events and mortality compared to other left ventricular assist devices, plus pump restart 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 combined with explicit mention of 'mortality associated with the system' in observational clinical data meets the criteria for Critical severity per the rubric. The agency is stopping all distribution due to neurological adverse events and device malfunction complaints.

Plain-English summary

Medtronic is recalling the HeartWare HVAD Outflow Graft (REF MCS1725OG) worldwide. This is a left ventricular assist device that assists a failing heart in pumping blood. A total of 459 units were distributed.

Mediatronic is halting distribution and sale based on observational clinical comparisons showing a higher frequency of neurological adverse events and mortality with this system compared to other commercially available left ventricular assist devices. Additionally, complaints indicate that the internal pump may delay or fail to restart.

The device was distributed in the United States and in multiple international locations including Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, Turkey, United Kingdom, and others. Patients who have received an HVAD device should contact their healthcare provider immediately to discuss these findings and review treatment options appropriate to their individual circumstances.

The recalled product

Product
HeartWare HVAD Outflow Graft, REF MCS1725OG
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiac Assist Device
Hazard
Affected units
459

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 (2)

  • GTIN: 00888707007627
  • 00888707007634 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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