The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-2058-2020·Announced 2020-06-03

Heartware HVAD Pump Outflow Graft Recalled for Potential Tears and Screw Breakage

Heartware, Inc. is recalling HVAD Pump Outflow Grafts because the graft may tear or the strain relief screw may break during pre-implant assembly.

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: The source text explicitly states the agency classification is Class I. Per the rubric, FDA Class I recalls are assigned a score of 5 (Critical) regardless of other factors.

Plain-English summary

Heartware, Inc. is recalling the Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125. The recall involves 20,147 devices that were distributed worldwide. All lots and serial numbers in distribution are affected.

The recall is being issued because the Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. This defect poses a risk of device failure during the surgical preparation process.

Healthcare providers and patients should contact Heartware, Inc. for instructions on how to proceed with the recall. The agency has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

The recalled product

Product
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiovascular
Hazard
Affected units
20,147

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)

  • All lots and serial numbers in distribution

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

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