FDA Device Recall Z-2058-2020

Heartware, Inc. · Miami Lakes, FL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125

Lot / serial / GTIN: All lots and serial numbers in distribution

Quantity: 20147 devices

Reason for recall

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.

Recall record

Recall number: Z-2058-2020
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide Distribution
Recall initiated: 2020-04-03
Classified by FDA Center: 2020-05-22
FDA published: 2020-06-03
Recalling firm: Heartware, Inc.
Firm location: Miami Lakes, FL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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