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HVAD Pump Implant Accessories recallZ-2059-2020 · Heartware, Inc. · initiated Apr 3, 2020

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Heartware, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-2059-2020
Status
Open, Classified
Initiated by the company
Apr 3, 2020
Recalling firm
Heartware, Inc.
Quantity
560 units
Product code
DSQ
FDA submissions
P100047
Distribution
Worldwide Distribution

Product description

Heartware HVAD Pump Implant accessories, Product (REF) Number 1153

Code information (models, lots, serial numbers)

GTIN 00888707000147, All lot numbers in distribution

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

33 devices cleared under P100047 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 85397).

Sources and updates

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