Heartware recalls HVAD System Controllers (models 1403, 1407, 1420) due to potential hairline cracks at power ports from water/fluid exposure. Affected units have serial numbers CON300175 to CON320540.
Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power ports of the controller housing.
Heartware is recalling specific HVAD System Controllers (models 1403, 1407, 1420) because they may develop hairline cracks at the power ports when exposed to water or fluids. This could lead to electrical issues or device failure in patients using the system for heart failure treatment.
The controllers may develop hairline cracks at the power ports when exposed to water or fluids. This could allow water or fluid to enter the device, potentially causing electrical malfunctions or device failure.
Patients using Heartware HVAD System Controllers with serial numbers CON300175 to CON320540 are affected. Those with the specific model numbers 1403, 1407, or 1420 are most at risk.
Check for the model numbers 1403, 1407, or 1420 on the controller. Affected units have serial numbers from CON300175 to CON320540 and are used for heart failure treatment.
Verify the serial number is between CON300175 and CON320540.
Reach out to Heartware directly for further instructions on the recall.
Model numbers 1403, 1407, and 1420.
They may develop hairline cracks at the power ports when exposed to water or fluids, potentially causing electrical issues.
Check for model numbers 1403, 1407, or 1420 and serial numbers CON300175 to CON320540.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-0067-2019 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0067-2019 from Heartware. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
