The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1993-2023·Announced 2023-06-28

HeartWare Ventricular Assist Device Monitor logfile processing failure

Heartware, Inc. is recalling 19 HeartWare Ventricular Assist Device System monitors (Model 1521 variants) because recently updated units cannot process downloaded logfiles in the Autologs web portal.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II medical device recall with no reported incidents, hospitalizations, or injuries. The hazard is a functional data-processing defect in a life-critical device, but no actual patient harm has been reported, placing this in the Moderate severity category.

Plain-English summary

Heartware, Inc. is recalling 19 HeartWare Ventricular Assist Device System monitors with Model 1521 (variants 1521US, 1521GB, 1521IL, and 1521DE). The affected monitors include specific serial numbers starting with MON4xxxxxx for international distribution and MON5xxxxxx for U.S. distribution.

The recently updated Model 1521 monitors have been identified with a data-processing failure. Logfiles downloaded from these monitors cannot be processed by the Autologs web portal, which is used to access and review device monitoring data. This incompatibility may impact the ability of clinicians to retrieve and review patient monitoring information.

The affected devices were distributed in the United States (Texas, Missouri, and Virginia) as well as internationally in Bahrain and the United Kingdom. Patients and healthcare providers using these specific monitor models should verify whether their devices are affected by checking their serial numbers.

Patients and healthcare providers should contact Heartware, Inc. immediately if they have an affected monitor. The manufacturer will provide information about corrective actions or device replacement options.

The recalled product

Product
HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
Manufacturer
Heartware, Inc.
Category
Medical Device — Ventricular Assist Device Monitor
Hazard
Affected units
19

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 (20)

  • a) Model Number 1521US
  • GTIN 00888707009256
  • Serial/Lot Numbers: MON500010
  • MON500012
  • MON500016
  • MON500028
  • MON500026
  • MON500005
  • MON500006
  • MON500007. b) Model Number 1521GB
  • GTIN 00888707006521
  • Serial/Lot Numbers: MON400039
  • MON400050
  • MON400051
  • MON400052
  • MON400053
  • MON400054
  • MON400061. c) Model Number 1521IL
  • GTIN 00888707010108
  • Serial/Lot Number: MON400017. d) Model Number 1521DE

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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