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Open, Classified

Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP

FDA Recall Z-2057-2020 · Posted None

Recalling FirmHeartware, Inc.
Recall StatusOpen, Classified
Product CodeDSQ
Date Initiated2020-04-03
Product Quantity85 units

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.

Firm Action

The firm disseminated a Medical Device Safety Alert by letter beginning on 04/03/2020. The notice explained he potential for damage that can occur during the procedure. Specifically, 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. The letter also provided additional steps for assembly and attachment to reduce the risk of damage and tearing during the assembly procedure which was provided in Appendix A.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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